Duns Number:597723837
Device Description: The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly avai The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly available multi-sample Luer adaptor; It is intended to facilitate collection of blood sample into either a culture bottle or standard vacuum blood tubes. It is a single use device.
Catalog Number
A100715
Brand Name
SampLok® Adapter Cap 2
Version/Model Number
A100715
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
K000777,K000777,K000777
Product Code
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Public Device Record Key
53d892e1-a719-493e-beda-e3e7ee3daf42
Public Version Date
April 23, 2019
Public Version Number
2
DI Record Publish Date
March 29, 2019
Package DI Number
19555240401226
Quantity per Package
12
Contains DI Package
19555240401219
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 |