Duns Number:092673953
Device Description: 3mL Vented Luer Slip Syringe 22g x 1" Needle, (~50IU)16.7IU/mL Balanced Heparin, Vented Ti 3mL Vented Luer Slip Syringe 22g x 1" Needle, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap, Q-Cork (Private Label)
Catalog Number
-
Brand Name
Atellica® VTR Syringes
Version/Model Number
11561348
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
K931924,K931924
Product Code
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Public Device Record Key
952e02d4-0565-41eb-b1ea-22cecc63c9cb
Public Version Date
March 08, 2022
Public Version Number
1
DI Record Publish Date
February 28, 2022
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |