GM-30 Inflation Device - 30atm-25cc Inflation Device. Features extended - INFRAREDX, INC.

Duns Number:124065421

Device Description: 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubing and 3 p 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.

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More Product Details

Catalog Number

GM-30NL

Brand Name

GM-30 Inflation Device

Version/Model Number

GM-30NL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PTM

Product Code Name

Syringe, Balloon Inflation, Exempt

Device Record Status

Public Device Record Key

03e0eb59-0a48-436f-a174-086fd21e645c

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INFRAREDX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13