Catalog Number

-

Brand Name

B500 SERIES

Version/Model Number

B505-1002N-10

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

-

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

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

47d7e244-1d79-4ec1-ad8f-a79144675457

Public Version Date

March 22, 2019

Public Version Number

1

DI Record Publish Date

March 14, 2019

Package DI Number

B5051002N103

Quantity per Package

1

Contains DI Package

B5051002N10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-