ONE-CARE OPTI Insulin Safety Syringes

FDA UDI

Class II (US FDA UDI)

by MediVena, LLC

Identity

Trade Name: ONE-CARE OPTI Insulin Safety Syringes FDA UDI
Generic Name: Metered-delivery hypodermic syringe/needle FDA UDI
Device Name: ONE-CARE OPTI Insulin Safety Syringes are single use devices intended for safe insulin delivery. They provide users with audible indication when the shield is pushed forward to permanently lock the needle (''Click''). One-hand activation of the safety mechanism provides ultimate convenience for the user. Precise graduation enhances visibility and accurate dosing. Large barrel flanges allow for secured grip and control of insulin dosing. FDA UDI
Model / Reference: ONE-CARE OPTI Insulin Safety Syringes, 0.5mL, 29G x 0.5'' FDA UDI
Description: ONE-CARE OPTI Insulin Safety Syringes are single use devices intended for safe insulin delivery. They provide users with audible indication when the shield is pushed forward to permanently lock the needle (''Click''). One-hand activation of the safety mechanism provides ultimate convenience for the user. Precise graduation enhances visibility and accurate dosing. Large barrel flanges allow for secured grip and control of insulin dosing. FDA UDI

Identifiers

Catalog Number: 2142 FDA UDI
Primary DI / UDI-DI: 00810008213995 FDA UDI
FDA Product Code: FMI FDA UDI
FMF FDA UDI
GMDN Term: Metered-delivery hypodermic 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

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: Total Volume — 0.5 Milliliter FDA UDI
Needle Gauge — 29 Gauge FDA UDI
Length — 0.5 Inch FDA UDI

Category: Metered-delivery hypodermic syringe/needle

ONE-CARE OPTI Insulin Safety Syringes by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: MediVena, LLC

Sources (1)

FDA UDI 61d73cc7-9f3d-49c4-abe4-0cd4355033c9 37 fields · synced May 31, 2026