Catalog Number

-

Brand Name

NA

Version/Model Number

S1001-2120

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

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

c1937eb8-61eb-4541-a955-a9301561304c

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

December 05, 2018

Package DI Number

04719873691234

Quantity per Package

2

Contains DI Package

04719873691227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-