True Comfort Pro Insulin Syringes 31G 1CC 5/16"

FDA UDI

Class II (US FDA UDI)

by Home Aide Diagnostics, Inc.

Identity

Trade Name: True Comfort Pro Insulin Syringes 31G 1CC 5/16" FDA UDI
Generic Name: Metered-delivery hypodermic syringe FDA UDI
Device Name: (1cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped. FDA UDI
Model / Reference: INS0131-0516 FDA UDI
Description: (1cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850027494098 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Metered-delivery hypodermic syringe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

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

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 0.3125 Inch FDA UDI
Needle Gauge — 31 Gauge FDA UDI

Category: Metered-delivery hypodermic syringe

True Comfort Pro Insulin Syringes 31G 1CC 5/16" by Home Aide Diagnostics, Inc. — 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: Home Aide Diagnostics, Inc.

Sources (1)

FDA UDI cf1abb91-c354-47ab-ae73-9214b66c6550 36 fields · synced Jun 8, 2026