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 standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty 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-30NF FDA UDI
Description: 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty 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-30NF FDA UDI
Primary DI / UDI-DI: 04543660022655 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

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

basixCOMPAK™ — Merit Medical Systems, Inc. · Class II
Monarch® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Infraredx, Inc.

Sources (1)

FDA UDI 9ba5c797-3b8e-4405-be74-9d7a14e115d7 37 fields · synced Jun 8, 2026