Catalog Number

61301606638

Brand Name

Getinge Assure AccuFast Biological Test Pack with 5 Controls

Version/Model Number

61301606638

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

61dc49f5-ce7c-4280-ba37-3ea4c4e1d6d2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

10814434020292

Quantity per Package

25

Contains DI Package

00814434020295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case