Custom Healthcare Systems Inc.

FDA UDI

Class I (US FDA UDI)

by Manus Medical, LLC

Identity

Trade Name: Custom Healthcare Systems Inc. FDA UDI
Generic Name: Closed-wound drainage kit FDA UDI
Model / Reference: D6-350 FDA UDI

Identifiers

Primary DI / UDI-DI: 00811870030352 FDA UDI
FDA Product Code: KXG FDA UDI
GMDN Term: Closed-wound drainage kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6025 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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Closed-wound drainage kit

Custom Healthcare Systems Inc. by Manus Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Closed-wound drainage kit.

Closed Wound Suction — C. R. Bard, Inc. · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
Closed Wound Suction — C. R. Bard, Inc. · Class I
BAROVAC® Evacuator Closed Wound Drainage System(SS) — Sewoon Medical Co., Ltd. · Class I
AVID TruCustom — AVID MEDICAL, INC. · Class II
SKATER™ Single Step Drainage Set — Argon Medical Devices, Inc. · Class I
Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class I

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: Manus Medical, LLC

Sources (1)

FDA UDI 99be0187-03f6-4eb8-a3dc-a89be069de64 32 fields · synced May 31, 2026