Catalog Number

-

Brand Name

NA

Version/Model Number

L1(D15)

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)

-

Over the Counter (OTC)

Yes

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

de37fd24-823a-4b20-aa0c-40f13fc91b7a

Public Version Date

May 20, 2020

Public Version Number

2

DI Record Publish Date

April 06, 2020

Package DI Number

16948538362270

Quantity per Package

35

Contains DI Package

06948538362273

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-