BioFlo

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name: BioFlo FDA UDI
Generic Name: Peripherally-inserted central venous catheter FDA UDI
Device Name: BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit FDA UDI
Model / Reference: 46-023 FDA UDI
Description: BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit FDA UDI

Identifiers

Primary DI / UDI-DI: H965460230 FDA UDI
FDA Product Code: PND FDA UDI
LJS FDA UDI
GMDN Term: Peripherally-inserted central venous catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5200 FDA UDI
880.5970 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Pressure — 181 Pound per Square Inch FDA UDI
Catheter Gauge — 4 French FDA UDI
Length — 20 Centimeter FDA UDI
Needle Gauge — 21 Gauge FDA UDI
Outer Diameter — 1.4 Millimeter FDA UDI

Category: Peripherally-inserted central venous catheter

BioFlo by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripherally-inserted central venous catheter.

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ARROW — TELEFLEX INCORPORATED · Class II
PowerPICC Provena — Bard Access Systems, Inc. · Class II
Synergy — Health Line International Corp · Class II
ARROW — TELEFLEX INCORPORATED · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Navilyst Medical, Inc.

Sources (1)

FDA UDI 9743d0c4-11c2-40a3-b92e-a765a0a548ac 36 fields · synced May 31, 2026