UltiCare

FDA UDI

Class II (US FDA UDI)

by Ulti Med, Inc.

Identity

Trade Name: UltiCare FDA UDI
Generic Name: Metered-delivery hypodermic syringe FDA UDI
Device Name: UltiCare Insulin Safety Syringes 1mL, 29G x 1/2" (.33mm x 12.7mm) U-100 5 x 100ct Sterile Safety Syringes FDA UDI
Model / Reference: 03219 FDA UDI
Description: UltiCare Insulin Safety Syringes 1mL, 29G x 1/2" (.33mm x 12.7mm) U-100 5 x 100ct Sterile Safety Syringes FDA UDI

Identifiers

Primary DI / UDI-DI: 10357515032192 FDA UDI
510(k) Number: K103011 FDA UDI
FDA Product Code: FMF FDA UDI
FMI FDA UDI
MEG FDA UDI
GMDN Term: Metered-delivery hypodermic syringe FDA UDI

Classification

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

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

Category: Metered-delivery hypodermic syringe

UltiCare by Ulti Med, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K103011 also covers:

UltiCare — ULTI MED, INC.

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: Ulti Med, Inc.

Sources (1)

FDA UDI 913fe375-ef66-4f94-a82e-dafb6b2ce21d 34 fields · synced Jun 8, 2026