Catalog Number

-

Brand Name

Trima Accel

Version/Model Number

82656

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

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

94bfd9bd-f80e-4f60-b4ef-c5daea0a7e02

Public Version Date

August 09, 2022

Public Version Number

4

DI Record Publish Date

February 15, 2017

Package DI Number

35020583826565

Quantity per Package

6

Contains DI Package

05020583826564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-