Catalog Number

GB130

Brand Name

Comfort Release

Version/Model Number

GB130

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

LRS

Product Code Name

I.V. Start Kit

Public Device Record Key

5266a221-55ae-45cd-b01d-76d8496deb37

Public Version Date

February 04, 2021

Public Version Number

1

DI Record Publish Date

January 27, 2021

Package DI Number

00850003442464

Quantity per Package

100

Contains DI Package

00850003442457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-