Catalog Number

-

Brand Name

B-CAPTA

Version/Model Number

1/4" VENOUS CUVETTE

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

K202154,K202154

Product Code

DRY

Product Code Name

MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Public Device Record Key

51356e1a-4035-434a-9ed9-19cbc1cb2b66

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

Package DI Number

38033178113091

Quantity per Package

10

Contains DI Package

08033178113090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX