PowerGlide Pro
DOT PG Pro 18G10cm RT Full BioPatch w/NG
12manufacturers in China registered for this device type
63catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls 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 | Bard Access Systems, Inc., 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 | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-10-30 |
| Record revised | 2026-01-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 10, case of 5, box of 2, case of 6, case of 4 |
| Sizes | Length 8 to 10 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F118087TX | Length 8 cm | In distribution |
| F318108TX | Length 10 cm | In distribution |
| PCK00008 | Length 10 cm | In distribution |
| F320088PTX | Length 8 cm | In distribution |
| F218081TX | Length 8 cm | In distribution |
| F220101TX | Length 10 cm | In distribution |
| F318088TX | Length 8 cm | In distribution |
| F122088PTX | Length 8 cm | In distribution |
| F420108PT | Length 10 cm | In distribution |
| F222081TX | Length 8 cm | In distribution |
| F118101TX | Length 10 cm | In distribution |
| F320107TX | Length 10 cm | In distribution |
| F120101DTX | Length 10 cm | In distribution |
| F422088PT | Length 8 cm | In distribution |
| F120087TX | Length 8 cm | In distribution |
| F220081TX | Length 8 cm | In distribution |
| F122081DTX | Length 8 cm | In distribution |
| F418108PT | Length 10 cm | In distribution |
| F122080TX | Length 8 cm | In distribution |
| PCK00007 | Length 8 cm | In distribution |
| F318107TX | Length 10 cm | In distribution |
| PCK00001 | Gauge | In distribution |
| F118088PTX | Length 8 cm | In distribution |
| F322088TX | Length 8 cm | In distribution |
| F420088PT | Length 8 cm | In distribution |
| F120081TX | Length 8 cm | In distribution |
| F218101TX | Length 10 cm | In distribution |
| F120100TX | Length 10 cm | In distribution |
| PCK00011 | Gauge | In distribution |
| F120081DTX | Length 8 cm | In distribution |
| F118101DTX | Length 10 cm | In distribution |
| F118081TX | Length 8 cm | In distribution |
| F118080TX | Length 8 cm | In distribution |
| PCK00005 | Gauge | In distribution |
| F120107TX | Length 10 cm | In distribution |
| F122087TX | Length 8 cm | In distribution |
| F320087TX | Length 8 cm | In distribution |
| F318087TX | Length 8 cm | In distribution |
| F120080TX | Length 8 cm | In distribution |
| F320088TX | Length 8 cm | In distribution |
| F320108TX | Length 10 cm | In distribution |
| F120101TX | Length 10 cm | In distribution |
| F122081TX | Length 8 cm | In distribution |
| F118081DTX | Length 8 cm | In distribution |
| F322088PTX | Length 8 cm | In distribution |
| F218088PTX | Length 8 cm | In distribution |
| F318108PTX | Length 10 cm | In distribution |
| F222088PTX | Length 8 cm | In distribution |
| F220108PTX | Length 10 cm | In distribution |
| F318088PTX | Length 8 cm | In distribution |
| PCK00012 | Length 10 cm | In distribution |
| F218108PTX | Length 10 cm | In distribution |
| F120088PTX | Length 8 cm | In distribution |
| F322087TX | Length 8 cm | In distribution |
| F418088PT | Length 8 cm | In distribution |
| F118108PTX | Length 10 cm | In distribution |
| F118107TX | Length 10 cm | In distribution |
| PCK00016 | Gauge | In distribution |
| F320108PTX | Length 10 cm | In distribution |
| F118100TX | Length 10 cm | In distribution |
| F220088PTX | Length 8 cm | In distribution |
| F120108PTX | Length 10 cm | In distribution |
| PCK00006 | Length 10 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 2,368 |
| Cook | Cook Incorporated | 250 |
| Cook Spectrum | Cook Incorporated | 225 |
| Jelco | ICU Medical, Inc | 104 |
| Medline | Medline Industries, Inc. | 95 |
| Deltaven Fast Flash | Delta Med SpA | 77 |
| Deltaven | Delta Med SpA | 73 |
| 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 |
|---|---|
| K971991 | 1997-11-07 |
| K971990 | 1997-11-07 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2014-08-08 | Class II | Nonconforming Material/Component | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), Power | 4375 units | 2015-08-05 |
| 2013-12-06 | Class II | Process control | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device. | 1358 | 2014-08-05 |
| 2013-12-06 | Class II | Process control | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device. | 200 | 2014-08-05 |
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.