BioFlo
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
12manufacturers in China registered for this device type
24catalogue numbers in this listing
2510(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 | Navilyst Medical, 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 |
| Record published | 2016-09-20 |
| Record revised | 2021-06-28 (version 6) |
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 |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Box of 5 |
| Sizes | Catheter gauge 3 to 5 Fr; outer diameter 1.02 to 1.73 mm; length 20 cm; needle gauge 21 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 46470 | Catheter Gauge 4 Fr | In distribution |
| 46016 | Needle Gauge 21 G | In distribution |
| 46490 | Needle Gauge 21 G | In distribution |
| 46510 | Catheter Gauge 3 Fr | In distribution |
| 46071 | Length 20 cm | In distribution |
| 46710 | Catheter Gauge 5 Fr | In distribution |
| 46015 | Needle Gauge 21 G | In distribution |
| 46018 | Outer Diameter 1.73 mm | In distribution |
| 46014 | Catheter Gauge 5 Fr | In distribution |
| 46061 | Outer Diameter 1.4 mm | In distribution |
| 46460 | Length 20 cm | In distribution |
| 46810 | Outer Diameter 1.73 mm | In distribution |
| 46610 | Outer Diameter 1.4 mm | In distribution |
| 46410 | Catheter Gauge 5 Fr | In distribution |
| 46013 | Outer Diameter 1.68 mm | In distribution |
| 46012 | Outer Diameter 1.4 mm | In distribution |
| 46081 | Length 20 cm | In distribution |
| 46091 | Needle Gauge 21 G | In distribution |
| 46480 | Outer Diameter 1.68 mm | In distribution |
| 46310 | Catheter Gauge 5 Fr | In distribution |
| 46210 | Length 20 cm | In distribution |
| 46017 | Needle Gauge 21 G | In distribution |
| 46051 | Catheter Gauge 3 Fr | In distribution |
| 46190 | Catheter Gauge 3 Fr | 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 |
| BD Cathena™ Safety IV Catheter | Becton, Dickinson AND Company | 59 |
Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161866 | 2016-09-08 |
| K150407 | 2015-05-15 |
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.