GM-30 Inflation Device GM-30NF

GUDID 04543660022655

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.

INFRAREDX, INC.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 04543660022655
• NIH Device Record Key: 9ba5c797-3b8e-4405-be74-9d7a14e115d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GM-30 Inflation Device
• Version Model Number: GM-30NF
• Catalog Number: GM-30NF
• Company DUNS: 124065421
• Company Name: INFRAREDX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com

Device Dimensions

• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0
• Total Volume: 25 Milliliter
• Pressure: 30 Atmosphere
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	04543660022655 [Primary]

FDA Product Code

• PTM: Syringe, Balloon Inflation, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-15
• Device Publish Date: 2021-03-05

On-Brand Devices [GM-30 Inflation Device ]

• 04543660022662: 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubing and 3 positio
• 04543660022655: 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 4 positio
• 04543660022648: 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 3 positio