Catalog Number

PFDFxs-Right B

Brand Name

PulseFlow DF™

Version/Model Number

PB01 Right B

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

-

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

K150806,K150806

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

d1494353-5ab4-4dfb-94e8-a1a1af9df748

Public Version Date

May 03, 2022

Public Version Number

2

DI Record Publish Date

December 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-