Catalog Number

D81

Brand Name

Allied Healthcare Products, Inc.

Version/Model Number

0V000001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

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

K872113

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

0cbe04de-cfb6-4029-95b0-5d4219b60f83

Public Version Date

January 13, 2020

Public Version Number

4

DI Record Publish Date

November 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-