Duns Number:070556204
Device Description: Curaplex AED Response Kit
Catalog Number
36147-2
Brand Name
Curaplex
Version/Model Number
36147-2
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
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
-
Product Code
CBP
Product Code Name
Valve, non-rebreathing
Public Device Record Key
f63bfae7-c1ae-4751-ace6-aca1a022eaaa
Public Version Date
August 16, 2022
Public Version Number
4
DI Record Publish Date
December 14, 2016
Package DI Number
00810094570255
Quantity per Package
50
Contains DI Package
00815277027618
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |