Catalog Number

1058MM

Brand Name

Unomedical, Mouth to Mask Resuscitator with Filter Adult Mask

Version/Model Number

1058MM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2022

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

K873286,K873286,K873286

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

bd6310f6-2b23-415e-bd72-cdf0e60cc05e

Public Version Date

May 23, 2022

Public Version Number

5

DI Record Publish Date

October 15, 2015

Package DI Number

10844249000622

Quantity per Package

10

Contains DI Package

00084424900061

Package Discontinue Date

May 20, 2022

Package Status

Not in Commercial Distribution

Package Type

carton