Duns Number:597723837
Device Description: SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with SAC 3 to fa SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with SAC 3 to facilitate collection of blood sample into vacuum tube(s). It is a single use device.
Catalog Number
A100763
Brand Name
SampLok® Adapter Cap 3 Insert
Version/Model Number
A100763
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
596fd7a5-cc8a-4330-878d-46f3b1c0a07b
Public Version Date
April 23, 2019
Public Version Number
2
DI Record Publish Date
March 29, 2019
Package DI Number
19555240401554
Quantity per Package
1000
Contains DI Package
09555240401557
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 |