SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder

FDA UDI

Class II (US FDA UDI)

by Sol-Millennium Medical, Inc.

Identity

Trade Name: SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder FDA UDI
Generic Name: Needle guard FDA UDI
Device Name: SOL-CARE Safety Blood Collection Needle w/Pre-attached Holder 25G*3/4*12inch FDA UDI
Model / Reference: 110201030010 FDA UDI
Description: SOL-CARE Safety Blood Collection Needle w/Pre-attached Holder 25G*3/4*12inch FDA UDI

Identifiers

Primary DI / UDI-DI: 00818392015621 FDA UDI
FDA Product Code: JKA FDA UDI
GMDN Term: Needle guard FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1675 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: Length — 20 Millimeter FDA UDI
Needle Gauge — 25 Gauge FDA UDI

Category: Blood collection set, invasive Needle guard

SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder by Sol-Millennium Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Needle guard.

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DropSafe Syringe with Safety Needle — HTL STREFA S A · Class II
Monoject — Cardinal Health 200, LLC · Class II
EasyPoint® — Retractable Technologies, 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

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Manufacturer

Manufacturer: Sol-Millennium Medical, Inc.

Sources (1)

FDA UDI 3561da37-fbfc-4279-ad1c-b547a34c1a7d 35 fields · synced Jun 9, 2026