Catalog Number

M1002

Brand Name

N/A

Version/Model Number

MD1002

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

K990659,K990659

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

b332b6e7-25c8-469e-84c4-29e558d2af08

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 03, 2017

Package DI Number

10607411944069

Quantity per Package

25

Contains DI Package

00607411944062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-