Catalog Number

22-000893-04

Brand Name

BIOTRANS™ Pressure Monitoring Kits

Version/Model Number

BTR W/O IFU-BULK PACK(NON-STERILE)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2020

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

DRS

Product Code Name

Transducer, Blood-Pressure, Extravascular

Public Device Record Key

88091cb7-045d-49e7-aae6-7ea33992583a

Public Version Date

December 01, 2020

Public Version Number

6

DI Record Publish Date

September 01, 2016

Package DI Number

98888893314030

Quantity per Package

3

Contains DI Package

78888893314036

Package Discontinue Date

December 01, 2020

Package Status

Not in Commercial Distribution

Package Type

CTN