Catalog Number

2320

Brand Name

N/A

Version/Model Number

N/A

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"

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

K081238,K081238

Product Code

NLF

Product Code Name

OXIMETER, REPROCESSED

Public Device Record Key

4a153a72-c16e-456d-a99e-8fef4b740b48

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

50885825016635

Quantity per Package

20

Contains DI Package

00885825016630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case