Catalog Number

TWPD1DA032015

Brand Name

Oxxiom

Version/Model Number

1612

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K200537

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

ce4ac030-2c01-4bb9-8a2a-b0ae9fe89f23

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

December 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-