Duns Number:070556204
Device Description: *Custom* ADPH Opioid OD Multipack Kit
Catalog Number
8600-01317-10NAL
Brand Name
Curaplex
Version/Model Number
8600-01317-10NAL
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
Yes
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
9cc95f5a-f7f7-4572-abef-71bf91d6ea60
Public Version Date
August 16, 2022
Public Version Number
2
DI Record Publish Date
December 30, 2020
Package DI Number
00810094572709
Quantity per Package
40
Contains DI Package
00812277036329
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 |