True-Comfort Pen Needles 4mm

FDA UDI

Class II (US FDA UDI)

by Home Aide Diagnostics, Inc.

Identity

Trade Name: True-Comfort Pen Needles 4mm FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: 100ct box. 32G x 5/32 (4mm) Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped. FDA UDI
Model / Reference: I23204 or INSP32-4 FDA UDI
Description: 100ct box. 32G x 5/32 (4mm) Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped. FDA UDI

Identifiers

Catalog Number: 1775 FDA UDI
Primary DI / UDI-DI: 00850058864105 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 4 Micrometer FDA UDI
Needle Gauge — 32 Gauge FDA UDI

Category: Hypodermic needle, single-use

True-Comfort Pen Needles 4mm 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 8465b2ea-932f-4d7a-8b92-a0c7dfb78ea2 37 fields · synced Jun 8, 2026