Catalog Number

IFT30350

Brand Name

ASTOTUBE®

Version/Model Number

IFT30350

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"

-

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

K991160,K991160

Product Code

BSB

Product Code Name

Warmer, blood, non-electromagnetic radiation

Public Device Record Key

e308851b-dc70-4032-874e-40b597c2f9b4

Public Version Date

October 10, 2022

Public Version Number

4

DI Record Publish Date

September 07, 2016

Package DI Number

04260114140412

Quantity per Package

50

Contains DI Package

04260114140627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-