Duns Number:010712461
Device Description: RESUS,ADL,HANDLE,MASK,OXY TUBE,RESV 10/CA
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
301-C1500
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
d5195284-0f35-4b2e-a75b-692a435431eb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 16, 2016
Package DI Number
00812574020847
Quantity per Package
10
Contains DI Package
00812574025545
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |