Duns Number:080593067
Device Description: SCALP VEIN INFUSION SET TYPE BUTTERFLY 21G
Catalog Number
M810
Brand Name
MEDADV
Version/Model Number
M810
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
K083687
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
53213349-ceb3-424a-aadb-ea1926ea8506
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 09, 2018
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 40 |