Duns Number:025460908
Device Description: DBD-SYRINGE,INSULIN,1ML,29GX1/2"
Catalog Number
INS012905
Brand Name
Medline
Version/Model Number
INS012905
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 29, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
79bbd11b-5096-4e8d-91df-2b68e02263ec
Public Version Date
June 29, 2022
Public Version Number
2
DI Record Publish Date
January 28, 2022
Package DI Number
40884389593579
Quantity per Package
100
Contains DI Package
30884389593572
Package Discontinue Date
June 29, 2022
Package Status
Not 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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |