Catalog Number

HEMCSM10

Brand Name

HemoSphere

Version/Model Number

HEMCSM10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K201446,K213682

Product Code

DQE

Product Code Name

Catheter, Oximeter, Fiber-Optic

Public Device Record Key

14a97c9b-f059-4bca-adc7-07573b68ac8f

Public Version Date

August 10, 2022

Public Version Number

3

DI Record Publish Date

July 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-