Duns Number:597723837
Device Description: SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood bags or o SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
Catalog Number
A100740
Brand Name
SampLok® Sampling Kit 16mL
Version/Model Number
A100740
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
BK030087,BK030087
Product Code
KSS
Product Code Name
Supplies, Blood-Bank
Public Device Record Key
d8cd871a-48c5-4ea9-9559-0ab7c2d1702d
Public Version Date
May 11, 2022
Public Version Number
3
DI Record Publish Date
March 29, 2019
Package DI Number
19555240400533
Quantity per Package
80
Contains DI Package
09555240400536
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 |