Catalog Number

-

Brand Name

HAEMONETICS CELL SAVER ELITE SYSTEM

Version/Model Number

CSE-B-1000

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

K101907,K101907,K101907

Product Code

CAC

Product Code Name

Apparatus, Autotransfusion

Public Device Record Key

b15db8c5-2231-4224-8cd5-68139b28bc71

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

August 16, 2017

Package DI Number

30812747016562

Quantity per Package

2

Contains DI Package

20812747016565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton