Catalog Number

-

Brand Name

Haemonetics

Version/Model Number

SQ40S

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"

Yes

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

K960993,K960993

Product Code

CAK

Product Code Name

Microfilter, blood transfusion

Public Device Record Key

50245594-ea00-411b-a3c7-68f5c55a1c4f

Public Version Date

March 29, 2021

Public Version Number

1

DI Record Publish Date

March 19, 2021

Package DI Number

30887691000660

Quantity per Package

40

Contains DI Package

10887691000666

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-