Catalog Number

0089100

Brand Name

Plastic Cath'N Sleeve

Version/Model Number

0089100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 13, 2022

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

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Public Device Record Key

59d0cf86-2171-4e2f-9f1f-fcd0f08fe4c7

Public Version Date

May 18, 2022

Public Version Number

2

DI Record Publish Date

September 21, 2020

Package DI Number

10801741050203

Quantity per Package

50

Contains DI Package

00801741050206

Package Discontinue Date

December 31, 2019

Package Status

Not in Commercial Distribution

Package Type

CA