GM-30 Inflation Device

Basic Information

• Brand Name: GM-30 Inflation Device
• Primary DI: 04543660022662
• Version / Model: GM-30NL
• Catalog Number: GM-30NL
• Company Name: INFRAREDX, INC.
• Labeler DUNS: 124065421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-05
• Public Version: 1
• Public Version Date: 2021-03-15
• Public Version Status: New
• Public Device Record Key: 03e0eb59-0a48-436f-a174-086fd21e645c

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17541	Catheter/overtube balloon inflator, single-use	A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04543660022662	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	25	Milliliter
Device Size Text, specify			Tubing Length: 76 Centimeter
Pressure	30	Atmosphere

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry