Catalog Number

301.328.010

Brand Name

imtmedical

Version/Model Number

301.328.010

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

-

Product Code

BZO

Product Code Name

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Public Device Record Key

f74d9f04-c7ef-45e0-bccd-99d7c34a5a8d

Public Version Date

January 21, 2021

Public Version Number

1

DI Record Publish Date

January 13, 2021

Package DI Number

07640149380767

Quantity per Package

10

Contains DI Package

07640149381344

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case