True Comfort Pro Pen Needles 5MM 32G

FDA UDI

Class II (US FDA UDI)

by Home Aide Diagnostics, Inc.

Identity

Trade Name: True Comfort Pro Pen Needles 5MM 32G FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: 100ct box. 32G x 5mm Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped. FDA UDI
Model / Reference: I12015 or INSP31-5 FDA UDI
Description: 100ct box. 32G x 5mm Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped. FDA UDI

Identifiers

Catalog Number: 7102 FDA UDI
Primary DI / UDI-DI: 00850027494012 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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 — 5 Millimeter FDA UDI
Needle Gauge — 32 Gauge FDA UDI

Category: Hypodermic needle, single-use

True Comfort Pro Pen Needles 5MM 32G 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 e6f0f852-114f-412e-95f1-9027dfe20186 37 fields · synced May 31, 2026