Catalog Number

SA11Y-49

Brand Name

Caremed

Version/Model Number

SA11Y-49

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2019

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153184

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

3799f365-3fd5-4a16-ac94-32a5ef014e8c

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

November 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-