Cook Spectrum
Cook Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Power Injectable Triple Lumen
12manufacturers in China registered for this device type
225catalogue numbers in this listing
13510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shandong (3), Guangdong (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Foshan Special Medical Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | FOZ |
| Device type | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2021-02-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2022-02-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G47846 | In distribution | |
| G51586 | In distribution | |
| G20072 | In distribution | |
| G48069 | In distribution | |
| G10033 | In distribution | |
| G44014 | In distribution | |
| G36318 | In distribution | |
| G34509 | In distribution | |
| G24716 | In distribution | |
| G23763 | In distribution | |
| G51545 | In distribution | |
| G24721 | In distribution | |
| G24810 | In distribution | |
| G24717 | In distribution | |
| G49807 | In distribution | |
| G44801 | In distribution | |
| G36312 | In distribution | |
| G23655 | In distribution | |
| G47829 | In distribution | |
| G47832 | In distribution | |
| G53601 | In distribution | |
| G53600 | In distribution | |
| G24756 | In distribution | |
| G50822 | In distribution | |
| G21310 | In distribution | |
| G51538 | In distribution | |
| G24804 | In distribution | |
| G24760 | In distribution | |
| G43992 | In distribution | |
| G44812 | In distribution | |
| G20071 | In distribution | |
| G21052 | In distribution | |
| G24803 | In distribution | |
| G29420 | In distribution | |
| G10039 | In distribution | |
| G43993 | In distribution | |
| G31957 | In distribution | |
| G49817 | In distribution | |
| G43986 | In distribution | |
| G44013 | In distribution | |
| G48053 | In distribution | |
| G44433 | In distribution | |
| G32376 | In distribution | |
| G44804 | In distribution | |
| G21053 | In distribution | |
| G49805 | In distribution | |
| G44803 | In distribution | |
| G56277 | In distribution | |
| G44405 | In distribution | |
| G44126 | In distribution | |
| G56424 | In distribution | |
| G21055 | In distribution | |
| G24765 | In distribution | |
| G51548 | In distribution | |
| G47845 | In distribution | |
| G43983 | In distribution | |
| G50821 | In distribution | |
| G44434 | In distribution | |
| G50820 | In distribution | |
| G43996 | In distribution | |
| G48122 | In distribution | |
| G23769 | In distribution | |
| G51587 | In distribution | |
| G24757 | In distribution | |
| G34914 | In distribution | |
| G53012 | In distribution | |
| G44808 | In distribution | |
| G43998 | In distribution | |
| G24823 | In distribution | |
| G44815 | In distribution | |
| G43991 | In distribution | |
| G51267 | In distribution | |
| G47839 | In distribution | |
| G21054 | In distribution | |
| G47835 | In distribution | |
| G36221 | In distribution | |
| G24812 | In distribution | |
| G51542 | In distribution | |
| G10342 | In distribution | |
| G47825 | In distribution | |
| G24719 | In distribution | |
| G43997 | In distribution | |
| G48056 | In distribution | |
| G51540 | In distribution | |
| G49804 | In distribution | |
| G56425 | In distribution | |
| G51543 | In distribution | |
| G36222 | In distribution | |
| G43995 | In distribution | |
| G44003 | In distribution | |
| G51544 | In distribution | |
| G24755 | In distribution | |
| G44810 | In distribution | |
| G44006 | In distribution | |
| G35136 | In distribution | |
| G48059 | In distribution | |
| G43994 | In distribution | |
| G48117 | In distribution | |
| G29413 | In distribution | |
| G13196 | In distribution | |
| G48049 | In distribution | |
| G25809 | In distribution | |
| G44809 | In distribution | |
| G48047 | In distribution | |
| G24752 | In distribution | |
| G51585 | In distribution | |
| G51266 | In distribution | |
| G43127 | In distribution | |
| G10188 | In distribution | |
| G36219 | In distribution | |
| G36311 | In distribution | |
| G57004 | In distribution | |
| G51546 | In distribution | |
| G56423 | In distribution | |
| G51591 | In distribution | |
| G44807 | In distribution | |
| G36314 | In distribution | |
| G48064 | In distribution | |
| G44070 | In distribution | |
| G29418 | In distribution | |
| G30088 | In distribution | |
| G57494 | In distribution | |
| G44004 | In distribution | |
| G47827 | In distribution | |
| G57020 | In distribution | |
| G10348 | In distribution | |
| G48067 | In distribution | |
| G44800 | In distribution | |
| G21056 | In distribution | |
| G24809 | In distribution | |
| G24758 | In distribution | |
| G44005 | In distribution | |
| G44811 | In distribution | |
| G24822 | In distribution | |
| G44432 | In distribution | |
| G24805 | In distribution | |
| G49806 | In distribution | |
| G53599 | In distribution | |
| G47831 | In distribution | |
| G23768 | In distribution | |
| G44016 | In distribution | |
| G44814 | In distribution | |
| G44379 | In distribution | |
| G44406 | In distribution | |
| G44127 | In distribution | |
| G36252 | In distribution | |
| G51537 | In distribution | |
| G50818 | In distribution | |
| G24759 | In distribution | |
| G10042 | In distribution | |
| G51588 | In distribution | |
| G47844 | In distribution | |
| G24821 | In distribution | |
| G13048 | In distribution | |
| G56422 | In distribution | |
| G53602 | In distribution | |
| G23656 | In distribution | |
| G29416 | In distribution | |
| G24754 | In distribution | |
| G49803 | In distribution | |
| G24718 | In distribution | |
| G51539 | In distribution | |
| G44128 | In distribution | |
| G10453 | In distribution | |
| G48061 | In distribution | |
| G31956 | In distribution | |
| G43130 | In distribution | |
| G44015 | In distribution | |
| G10194 | In distribution | |
| G43984 | In distribution | |
| G48048 | In distribution | |
| G49815 | In distribution | |
| G51541 | In distribution | |
| G44802 | In distribution | |
| G48050 | In distribution | |
| G57005 | In distribution | |
| G44816 | In distribution | |
| G49802 | In distribution | |
| G21057 | In distribution | |
| G44008 | In distribution | |
| G24138 | In distribution | |
| G44007 | In distribution | |
| G10438 | In distribution | |
| G57019 | In distribution | |
| G20070 | In distribution | |
| G18300 | In distribution | |
| G10437 | In distribution | |
| G57006 | In distribution | |
| G57165 | In distribution | |
| G10452 | In distribution | |
| G24722 | In distribution | |
| G51589 | In distribution | |
| G48113 | In distribution | |
| G24673 | In distribution | |
| G43981 | In distribution | |
| G31955 | In distribution | |
| G10040 | In distribution | |
| G48076 | In distribution | |
| G10032 | In distribution | |
| G48124 | In distribution | |
| G51590 | In distribution | |
| G10196 | In distribution | |
| G50817 | In distribution | |
| G57495 | In distribution | |
| G34902 | In distribution | |
| G44813 | In distribution | |
| G23657 | In distribution | |
| G44806 | In distribution | |
| G44431 | In distribution | |
| G25332 | In distribution | |
| G43985 | In distribution | |
| G35951 | In distribution | |
| G10185 | In distribution | |
| G43982 | In distribution | |
| G10041 | In distribution | |
| G47833 | In distribution | |
| G21058 | In distribution | |
| G50819 | In distribution | |
| G24137 | In distribution | |
| G36315 | Withdrawn | |
| G44063 | Withdrawn | |
| G36220 | Withdrawn | |
| G53009 | Withdrawn | |
| G51547 | Withdrawn | |
| G36316 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 2,368 |
| Cook | Cook Incorporated | 250 |
| Jelco | ICU Medical, Inc | 104 |
| Medline | Medline Industries, Inc. | 95 |
| Deltaven Fast Flash | Delta Med SpA | 77 |
| Deltaven | Delta Med SpA | 73 |
| PowerGlide Pro | Bard Access Systems, Inc. | 63 |
| Peripheral Catheter Insertion Kit | Bard Access Systems, Inc. | 62 |
| Able Central Venous Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 62 |
| Curaplex | Bound Tree Medical, LLC | 61 |
| BD Cathena™ Safety IV Catheter | Becton, Dickinson AND Company | 59 |
| Cragg-McNamaraTM | Micro Therapeutics, Inc. | 57 |
Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182252 | 2019-05-17 |
| K100974 | 2010-05-06 |
| K081113 | 2008-07-30 |
| K081690 | 2008-07-14 |
| K060174 | 2006-02-17 |
| K033843 | 2004-08-12 |
| K032274 | 2004-02-26 |
| K021557 | 2003-05-30 |
| K013182 | 2002-07-01 |
| K010034 | 2001-01-24 |
| K992198 | 1999-08-27 |
| K950118 | 1996-02-08 |
| K772011 | 1979-06-15 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cook Incorporated | UDI-DI | 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 1872 units | |
| Cook Incorporated | UDI-DI | 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 5080 units | |
| Cook Incorporated | UDI-DI | 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 2348 units | |
| Cook Incorporated | UDI-DI | 2020-03-06 | Class II | Under Investigation by firm | The printed expiration dates are incorrect. | 25 | 2020-12-18 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-07-31 | Class II | Process control | Central venous catheters may not fit over guide wire potentially causing procedure delay. | 50 | 2019-05-08 |
| 2017-07-31 | Class II | Process control | Central venous catheters may not fit over guide wire potentially causing procedure delay. | 75 | 2019-05-08 |
| 2017-07-31 | Class II | Process control | Central venous catheters may not fit over guide wire potentially causing procedure delay. | 304 | 2019-05-08 |
| 2017-07-31 | Class II | Process control | Central venous catheters may not fit over guide wire potentially causing procedure delay. | 25 | 2019-05-08 |
| 2017-07-31 | Class II | Process control | Central venous catheters may not fit over guide wire potentially causing procedure delay. | 85 | 2019-05-08 |
| 2016-11-28 | Class II | Mixed-up of materials/components | Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing need | 99 units | 2017-09-06 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,743 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51, 473 trays all products | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51, 473 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,4736 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total trays | 2011-06-21 |
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.