Catalog Number

HSGPL1040

Brand Name

FLEXFORM LINE

Version/Model Number

HS GENERAL PURPOSE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

967df357-e391-42f4-b114-937a1b788554

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Package DI Number

28033055146337

Quantity per Package

5

Contains DI Package

08033055146333

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-