Duns Number:597723837
Device Description: SampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Individual Pac SampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Individual Packaged Sterile;Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests
Catalog Number
A100645
Brand Name
SampLok® System with Hinged Lid
Version/Model Number
A100645
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K021941,K021941
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
b1c619af-4e42-46bc-98be-716284af33cc
Public Version Date
April 08, 2019
Public Version Number
1
DI Record Publish Date
March 29, 2019
Package DI Number
19555240400007
Quantity per Package
425
Contains DI Package
19555240401158
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |