Duns Number:529725666
Catalog Number
-
Brand Name
Demax
Version/Model Number
DPD20/OFF
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
K140943,K140943
Product Code
MAV
Product Code Name
Syringe, Balloon Inflation
Public Device Record Key
1c887c15-dd65-4f34-9f05-45374dd0aba5
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
August 09, 2019
Package DI Number
16943718223082
Quantity per Package
20
Contains DI Package
06943718223085
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 62 |