PowerFlow, ChronoFlex

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name: PowerFlow, ChronoFlex FDA UDI
Generic Name: Apheresis kit FDA UDI
Device Name: PowerFlow 9.6Fr ChronoFlex Implantable Apheresis IV Port Intermediate Kit FDA UDI
Model / Reference: A710962 FDA UDI
Description: PowerFlow 9.6Fr ChronoFlex Implantable Apheresis IV Port Intermediate Kit FDA UDI

Identifiers

Catalog Number: A710962 FDA UDI
Primary DI / UDI-DI: 00801741129438 FDA UDI
FDA Product Code: PTD FDA UDI
GMDN Term: Apheresis kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5965 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

Yes

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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 9.6 French FDA UDI
Length — 45 Centimeter FDA UDI

Category: Apheresis kit

PowerFlow, ChronoFlex by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PowerFlow — Bard Access Systems, Inc. · Class II
PowerFlow — Bard Access 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

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Manufacturer

Manufacturer: Bard Access Systems, Inc.

Sources (1)

FDA UDI 1bf431be-39ab-4fc1-9010-778a17e30f7d 36 fields · synced Jun 9, 2026