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: 1ml Luer Slip TB with 25G x 5/8" Needle FDA UDI
Model / Reference: 303-2158 FDA UDI
Description: 1ml Luer Slip TB with 25G x 5/8" Needle FDA UDI

Identifiers

Primary DI / UDI-DI: 00786227221557 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 — 25 Gauge FDA UDI
Length — 0.625 Inch FDA UDI
Total Volume — 1 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Allison Medical, Inc.

Sources (1)

FDA UDI b6c049ff-8b5f-4efa-9e5c-edc9ae61e0e4 35 fields · synced May 30, 2026