Catalog Number

60386

Brand Name

Patient Circuit

Version/Model Number

60386

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"

-

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

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

bcd44b1d-9994-40c7-8a08-1980633b7007

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

September 08, 2015

Package DI Number

14942962603864

Quantity per Package

5

Contains DI Package

04942962603867

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box