Catalog Number

8-6200-0

Brand Name

Impulse Overwrap Bag Sealer 110v

Version/Model Number

8-6200-0

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Public Device Record Key

53480db0-46df-4208-becc-dca3c513bb95

Public Version Date

January 12, 2021

Public Version Number

4

DI Record Publish Date

April 05, 2017

Package DI Number

10886368000497

Quantity per Package

1

Contains DI Package

00886368000490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box