Catalog Number

421554

Brand Name

AVELLE

Version/Model Number

421554

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

K180205,K180205,K180205

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

6ce32c14-2e5f-45c0-9c55-5e86cd6550ea

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Package DI Number

00768455148899

Quantity per Package

5

Contains DI Package

00768455139279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton