BioFlo

BioFlo Midline with ENDEXO Technology (5F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit

Registry build 21.09.26
1manufacturer
4catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code PND
Manufacturer City Province Registered as Device types
Terumo Medical Products (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7

Record

Regulatory record for BioFlo
Listed by Navilyst Medical, Inc., United States
FDA product code PND
Device type Midline Catheter
Device class Class 2
Regulation 21 CFR 880.5200
Record published 2019-06-04
Record revised 2024-03-25 (version 5)

Specifications

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 Needle gauge 21 G; outer diameter 1.02 to 1.73 mm; catheter gauge 3 to 5 Fr; pressure 153 to 181 psi; length 20 cm

Catalogue Numbers

Catalogue numbers for BioFlo
Catalogue number Size Status
46-024 Needle Gauge 21 G In distribution
46-029 Length 20 cm In distribution
46-022 Length 20 cm In distribution
46-023 Pressure 181 psi In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Midline Catheter Kit Bard Access Systems, Inc. 68
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Provena Midline Bard Access Systems, Inc. 31
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primeMIDLINE PFM Medical, Inc 6
Provena Bard Access Systems, Inc. 5
PowerGlide ST Bard Access Systems, Inc. 3
CT Midline Catheter Medical Components Inc 3
20G 8CM Stiletto Extended Dwell Catheter Avia Vascular 1
Arch-FLO CT Midlinearch-FLO CT Midline Medical Components Inc 1

Showing 12 of 14. All products under Midline Catheter

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer