Catalog Number

-

Brand Name

Capiox® Hardshell Reservoir

Version/Model Number

CX*CRXA

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

K030505,K030505

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Public Device Record Key

432591e7-58d6-414b-a70a-226b1d481708

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

October 02, 2015

Package DI Number

50699753450399

Quantity per Package

4

Contains DI Package

00699753450394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4 Piece Case