Duns Number:687844027
Device Description: 4 CHAMBER DEVICE
Catalog Number
UAM-8100
Brand Name
AIR RELAX
Version/Model Number
UAM-8100
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
-
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
K130385
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
b3ee306e-fe5a-407b-ba15-add3e3787bf7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 14, 2017
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. | 22 |