Closed Wound Suction

FDA UDI

Class I (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name: Closed Wound Suction FDA UDI
Generic Name: Closed-wound drainage kit FDA UDI
Device Name: CWS 400 Closed Wound Suction Kit, 400cc Evauactor, 3-spring, Y-Connecting Tube FDA UDI
Model / Reference: 0043650 FDA UDI
Description: CWS 400 Closed Wound Suction Kit, 400cc Evauactor, 3-spring, Y-Connecting Tube FDA UDI

Identifiers

Catalog Number: 0043650 FDA UDI
Primary DI / UDI-DI: 00801741049385 FDA UDI
FDA Product Code: GCY FDA UDI
GMDN Term: Closed-wound drainage kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4680 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Closed-wound drainage kit

Closed Wound Suction by C. R. Bard, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Closed-wound drainage kit.

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BAROVAC® Evacuator Closed Wound Drainage System(SS) — Sewoon Medical Co., Ltd. · Class I
AVID TruCustom — AVID MEDICAL, INC. · Class II
Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
SKATER™ Single Step Drainage Set — Argon Medical Devices, Inc. · Class I
Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class I
ACCEL® — B. Braun Melsungen Aktiengesellschaft · 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 I	Pending data

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Manufacturer

Manufacturer: C. R. Bard, Inc.

Sources (1)

FDA UDI c43a3bed-4795-4dc4-b54d-2ce8c19d15cc 35 fields · synced Jun 1, 2026