Custom Healthcare Systems Inc.

FDA UDI

Class II (US FDA UDI)

by Manus Medical, LLC

Identity

Trade Name: Custom Healthcare Systems Inc. FDA UDI
Generic Name: General-purpose syringe/needle FDA UDI
Model / Reference: B9-15321 FDA UDI

Identifiers

Primary DI / UDI-DI: 00811870031526 FDA UDI
FDA Product Code: LRO FDA UDI
GMDN Term: General-purpose syringe/needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 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

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: General-purpose syringe/needle

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

Similar devices

Also classified as General-purpose syringe/needle.

BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
CarePoint Precision — ALLISON MEDICAL, INC. · Class II
YI XIN Sterile Syringe For Single Use — Jiang Xi Sanxin Medtec Co., Ltd. · Class II
Micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD. · Class II
BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
Azur Medical Company Inc. — Azur Medical Company, Inc. · Class II
RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
CarePoint Precision — ALLISON MEDICAL, 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: Manus Medical, LLC

Sources (1)

FDA UDI d4070e1c-7127-4b60-b0a2-9c2f05eec756 32 fields · synced Jun 8, 2026