Duns Number:597723837
Device Description: SEG is intended to aid extraction of a biological fluid sample from a segmented piece of t SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
Catalog Number
A200200
Brand Name
Segment Sampler (SEG)
Version/Model Number
A200200
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
BK170102,BK170102,BK170102
Product Code
KSS
Product Code Name
Supplies, Blood-Bank
Public Device Record Key
2a6159a5-7a4a-4ea8-ab8f-0fd01b1b9665
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 19, 2020
Package DI Number
19555240401349
Quantity per Package
60
Contains DI Package
19555240401332
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box
| 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 |