Catalog Number

-

Brand Name

Hydrogel Adhesive Strap

Version/Model Number

FP120-FOT01-003

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

K200337,K200337

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Public Device Record Key

7f700a65-1628-42bc-b3ce-e36753334528

Public Version Date

June 27, 2022

Public Version Number

1

DI Record Publish Date

June 17, 2022

Package DI Number

10627987360117

Quantity per Package

10

Contains DI Package

00627987360110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag