Catalog Number

-

Brand Name

Drive

Version/Model Number

18705

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)

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

7d72c3e9-e04b-4070-9b60-939d12a974fb

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10822383173419

Quantity per Package

250

Contains DI Package

00822383173412

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-