Catalog Number

-

Brand Name

BCI

Version/Model Number

WW1018G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K083557,K083705,K083787

Product Code

DPZ

Product Code Name

Oximeter, ear

Public Device Record Key

25b897c1-4134-4815-880f-e326cf4bec20

Public Version Date

January 21, 2020

Public Version Number

1

DI Record Publish Date

January 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-