CarePoint Precision

FDA UDI

Class II (US FDA UDI)

by Allison Medical, Inc.

Identity

Trade Name: CarePoint Precision FDA UDI
Generic Name: General-purpose syringe/needle FDA UDI
Device Name: 3ml Luer Lock Syringe w/ 22G x 1.5" FDA UDI
Model / Reference: 505-3125 FDA UDI
Description: 3ml Luer Lock Syringe w/ 22G x 1.5" FDA UDI

Identifiers

Primary DI / UDI-DI: 00786227053653 FDA UDI
510(k) Number: K124037 FDA UDI
FDA Product Code: FMI FDA UDI
FMF FDA UDI
GMDN Term: General-purpose syringe/needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
880.5860 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

Dimensions & Sizes

Size: Needle Gauge — 22 Gauge FDA UDI
Length — 1.5 Inch FDA UDI
Total Volume — 3 Milliliter FDA UDI

Category: General-purpose syringe/needle

CarePoint Precision by Allison Medical, Inc. — 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
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
Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
CAINA — Jiangsu Caina Medical Co., Ltd · Class II

Cleared under the same submission

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: Allison Medical, Inc.

Sources (1)

FDA UDI 684a1b27-6e9f-40d8-bdd0-c20eae579f6e 35 fields · synced May 30, 2026