Catalog Number

-

Brand Name

Transonic

Version/Model Number

H36AUL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 13, 2021

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K872048

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Public Device Record Key

b70398ae-70dc-45a5-a7f5-9fa76f7d62b1

Public Version Date

September 14, 2021

Public Version Number

5

DI Record Publish Date

April 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-