Catalog Number

6635

Brand Name

Q-Care

Version/Model Number

6635

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"

Yes

For Single-Use

Yes

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

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

ced6fc1c-2979-42c8-a6d6-705561c09083

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

50618029800911

Quantity per Package

100

Contains DI Package

00618029800916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case