Duns Number:081840873
Device Description: VENAFLOW ELITE THIGH CUFF - 20 PAIRS
Catalog Number
-
Brand Name
AIRCAST
Version/Model Number
24-3045
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOW
Product Code Name
SLEEVE, LIMB, COMPRESSIBLE
Public Device Record Key
3d7a24bf-a4bc-41e4-87e5-44295a2442a8
Public Version Date
November 08, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
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 | 784 |
2 | A medical device with a moderate to high risk that requires special controls. | 1030 |
3 | A medical device with high risk that requires premarket approval | 8 |