Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

18062

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

K042349,K042349

Product Code

JCX

Product Code Name

APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Public Device Record Key

c43fad2c-6945-481b-a8c4-a591a025b700

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

November 07, 2016

Package DI Number

50822383228698

Quantity per Package

6

Contains DI Package

00822383228693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-