GM-30 Inflation Device

FDA UDI

Class II (US FDA UDI)

by Infraredx, Inc.

Identity

Trade Name: GM-30 Inflation Device FDA UDI
Generic Name: Catheter/overtube balloon inflator, single-use FDA UDI
Device Name: 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubing and 3 position stopcock for balloon inflation and deflation. Indications for Use: 1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. FDA UDI
Model / Reference: GM-30NL FDA UDI
Description: 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubing and 3 position stopcock for balloon inflation and deflation. Indications for Use: 1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. FDA UDI

Identifiers

Catalog Number: GM-30NL FDA UDI
Primary DI / UDI-DI: 04543660022662 FDA UDI
FDA Product Code: PTM FDA UDI
GMDN Term: Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1650 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

Dimensions & Sizes

Size: Total Volume — 25 Milliliter FDA UDI
Pressure — 30 Atmosphere FDA UDI

Category: Catheter/overtube balloon inflator, single-use

GM-30 Inflation Device by Infraredx, 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: Infraredx, Inc.

Sources (1)

FDA UDI 03e0eb59-0a48-436f-a174-086fd21e645c 37 fields · synced Jun 8, 2026