True Flow

FDA UDI

Class II (US FDA UDI)

by Bard Peripheral Vascular

Identity

Trade Name: TRUE FLOW FDA UDI
Generic Name: Cardiac valvuloplasty catheter FDA UDI
Device Name: TRUE™ FLOW Valvuloplasty Perfusion Catheter, 18 mm x 3.5 cm, 110 cm catheter FDA UDI
Model / Reference: TF0183511 FDA UDI
Description: TRUE™ FLOW Valvuloplasty Perfusion Catheter, 18 mm x 3.5 cm, 110 cm catheter FDA UDI

Identifiers

Catalog Number: TF0183511 FDA UDI
Primary DI / UDI-DI: 00801741097645 FDA UDI
FDA Product Code: OZT FDA UDI
GMDN Term: Cardiac valvuloplasty catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1255 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Category: Cardiac valvuloplasty catheter

True Flow by Bard Peripheral Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac valvuloplasty catheter.

Z-MED II™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
NuCLEUS-X™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
TYSHAK® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
Z-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
TYSHAK NuCLEUS™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
Z-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
Z-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bard Peripheral Vascular

Sources (1)

FDA UDI 6f4c157d-b5f8-4094-abea-60d7e247efd1 36 fields · synced May 30, 2026