Duns Number:170199058
Device Description: For use with injectors for the subcutaneous injection of approved drugs, including insulin
Catalog Number
AN 3829AH
Brand Name
Ahold - CareOne UPP 12mm pen needles
Version/Model Number
AN 3829AH
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152339,K152339,K152339,K152339
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
01b11538-3352-433a-9738-0c4eb7742e84
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
10041520090857
Quantity per Package
24
Contains DI Package
00041520090850
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |
| U | Unclassified | 2 |