Catalog Number

-

Brand Name

Curaplex

Version/Model Number

301-C4000

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

K021442,K021442

Product Code

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Public Device Record Key

2b88ec7f-93b3-443e-82b7-e8f580c90ae4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 14, 2016

Package DI Number

00812574025620

Quantity per Package

10

Contains DI Package

00812574020885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-