BD Cathena™ Safety IV Catheter
BD Cathena™ Safety IV Catheter with Wings 20 GA x 1.00 IN
12manufacturers in China registered for this device type
59catalogue numbers in this listing
6510(k) clearances naming this product 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 | Becton, Dickinson AND Company, 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, Repacker / relabeller, Manufacturer |
| Record published | 2022-08-04 |
| Record revised | 2025-07-30 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Room Temperature |
| Packaging | Case of 4, shelfpack of 30, shelfpack of 50 |
| Sizes | Length 0.75 to 2 in; length 19 to 51 mm; needle gauge 18 to 22 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 386871 | Length 1 in | In distribution |
| 386874 | Length 2 in | In distribution |
| 386873 | Needle Gauge 20 G | In distribution |
| 386817 | Length 51 mm | In distribution |
| 386883 | Flow Rate = 64 millilitre per minute (mL or ml/min) | In distribution |
| 386865 | Length 1.25 in | In distribution |
| 386862 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 386813 | Size = Catheter Gauge = 22 Gauge (G) | In distribution |
| 386811 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 386815 | Length 19 mm | In distribution |
| 386803 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 386880 | Length 0.75 in | In distribution |
| 386879 | Size = Catheter Gauge = 24 Gauge (G) | In distribution |
| 386876 | Needle Gauge 18 G | In distribution |
| 386891 | Length 2 in | In distribution |
| 386820 | Size = Catheter Gauge = 16 Gauge (G) | In distribution |
| 386866 | Length 2 in | In distribution |
| 386885 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 386872 | Length 1 in | In distribution |
| 386869 | Length 1.25 in | In distribution |
| 386863 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 386806 | Length 25 mm | In distribution |
| 386861 | Flow Rate = 36 millilitre per minute (mL or ml/min) | In distribution |
| 386894 | Flow Rate = 65 millilitre per minute (mL or ml/min) | In distribution |
| 386859 | Length 0.75 in | In distribution |
| 386814 | Size = Catheter Gauge = 22 Gauge (G) | In distribution |
| 386893 | Needle Gauge 22 G | In distribution |
| 386881 | Length 1 in | In distribution |
| 386897 | Flow Rate = 104 millilitre per minute (mL or ml/min) | In distribution |
| 386868 | Flow Rate = 176 millilitre per minute (mL or ml/min) | In distribution |
| 386875 | Length 1.25 in | In distribution |
| 386810 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 386802 | Flow Rate = 87 millilitre per minute (mL or ml/min) | In distribution |
| 386812 | Length 51 mm | In distribution |
| 386805 | Length 51 mm | In distribution |
| 386896 | Length 2 in | In distribution |
| 386887 | Flow Rate = 87 millilitre per minute (mL or ml/min) | In distribution |
| 386886 | Size = Catheter Gauge = 18 Gauge (G) | In distribution |
| 386888 | Length 1.25 in | In distribution |
| 386818 | Size = Catheter Gauge = 24 Gauge (G) | In distribution |
| 386895 | Needle Gauge 20 G | In distribution |
| 386807 | Length 19 mm | In distribution |
| 386867 | Flow Rate = 190 millilitre per minute (mL or ml/min) | In distribution |
| 386808 | Length 32 mm | In distribution |
| 386816 | Length 32 mm | In distribution |
| 386882 | Length 2 in | In distribution |
| 386809 | Length 51 mm | In distribution |
| 386898 | Length 2 in | In distribution |
| 386889 | Size = Catheter Gauge = 16 Gauge (G) | In distribution |
| 386890 | Flow Rate = 212 millilitre per minute (mL or ml/min) | In distribution |
| 386892 | Length 1 in | In distribution |
| 386860 | Size = Catheter Gauge = 24 Gauge (G) | In distribution |
| 386801 | Flow Rate = 94 millilitre per minute (mL or ml/min) | In distribution |
| 386819 | Size = Catheter Gauge = 16 Gauge (G) | In distribution |
| 386864 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 386884 | Flow Rate = 60 millilitre per minute (mL or ml/min) | In distribution |
| 386804 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 386870 | Length 2 in | In distribution |
| 386821 | Flow Rate = 20 millilitre per minute (mL or ml/min) | 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 |
| 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 |
| 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 |
|---|---|
| K200891 | 2021-06-02 |
| K201075 | 2020-12-18 |
| K172506 | 2017-09-17 |
| K172204 | 2017-08-17 |
| K170336 | 2017-03-10 |
| K170283 | 2017-02-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Becton Dickinson Infusion Therapy Systems Inc. | UDI-DI | 2023-08-29 | Class II | Process change control | There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed. | 98,000 units |
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.