Catalog Number

-

Brand Name

Drive

Version/Model Number

18720-ADPROBE

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

K090671,K090671

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

0fd785e6-b081-43ad-a196-36447bda31a2

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10822383549443

Quantity per Package

15

Contains DI Package

00822383549446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-