Duns Number:029062325
Device Description: Fluid Transfer Sets 8 Lead Harness with Port Adapter (6" L)
Catalog Number
CT-018-08
Brand Name
Advect
Version/Model Number
CT-018-08
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
BK170004,BK170004
Product Code
KSB
Product Code Name
Set, Transfer (Blood/Plasma)
Public Device Record Key
09fd809b-47ed-40c5-a737-1a376c797e17
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
February 01, 2019
Package DI Number
00817827026676
Quantity per Package
24
Contains DI Package
00817827026171
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| U | Unclassified | 7 |