Insufflator Filter Assembly

FDA UDI

Class II (US FDA UDI)

by Armm Inc.

Identity

Trade Name: Insufflator Filter Assembly FDA UDI
Generic Name: Endoscopic insufflation tubing set, single-use FDA UDI
Device Name: Insufflator Filter Assembly - Rotating Male Luer / Multiple Barb FDA UDI
Model / Reference: 21002 FDA UDI
Description: Insufflator Filter Assembly - Rotating Male Luer / Multiple Barb FDA UDI

Identifiers

Primary DI / UDI-DI: 10850082007193 FDA UDI
FDA Product Code: HIF FDA UDI
GMDN Term: Endoscopic insufflation tubing set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1730 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscopic insufflation tubing set, single-use

Insufflator Filter Assembly by Armm 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: Armm Inc.

Sources (1)

FDA UDI ad320043-571d-49cf-bcc7-550dcc6dcb2c 34 fields · synced Jun 1, 2026