Catalog Number

MAS2317

Brand Name

NA

Version/Model Number

MAS2317

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 17, 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

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

K092368,K092368

Product Code

NLF

Product Code Name

OXIMETER, REPROCESSED

Public Device Record Key

b8c0b35c-ac3c-4d73-bac4-c36cce3a4e1f

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

20888551042373

Quantity per Package

24

Contains DI Package

10888551042376

Package Discontinue Date

April 17, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton