Duns Number:070556204
Device Description: Curaplex Single-Dose Opioid Overdose Kit, Bagged (Fed Gov)
Catalog Number
670037-KIT-DOD
Brand Name
Curaplex
Version/Model Number
670037-KIT-DOD
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCQ
Product Code Name
NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
Public Device Record Key
d28ad4d9-288d-4f05-a5d4-69ad97a92640
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
February 28, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |