Catalog Number

-

Brand Name

Sil-Flex

Version/Model Number

77015

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

-

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

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Public Device Record Key

2a276345-b71f-4bad-ad8d-bb4d1cd32057

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

September 19, 2015

Package DI Number

44710810083301

Quantity per Package

4

Contains DI Package

24710810083307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton