Catalog Number

422285

Brand Name

AVELLE

Version/Model Number

422285

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

10161fc3-32e3-4406-af21-b1a8133b224a

Public Version Date

October 27, 2022

Public Version Number

2

DI Record Publish Date

September 09, 2022

Package DI Number

00768455155040

Quantity per Package

1

Contains DI Package

00768455155033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton