Duns Number:622637544
Device Description: OPTFlow SUB-Q 1 Needle set, 26ga RW x 4mm, 70cm Tubing with safety mechanism, Box of 10
Catalog Number
OPT12604-Q10
Brand Name
OPTFlow
Version/Model Number
OPT12604-Q10
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"
Yes
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
K140131,K140131
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
9f1e94f8-0084-4ef2-9b79-51cb81a679db
Public Version Date
December 15, 2020
Public Version Number
1
DI Record Publish Date
December 07, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 26 |