Duns Number:054326178
Device Description: Sage Air Tap Lift Compatible
Catalog Number
7287
Brand Name
Sage Air Tap LC
Version/Model Number
7287
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMP
Product Code Name
Protector, skin pressure
Public Device Record Key
148c9a4e-eb31-4d60-86e4-aa063c894218
Public Version Date
July 04, 2022
Public Version Number
6
DI Record Publish Date
October 01, 2019
Package DI Number
50618029720806
Quantity per Package
5
Contains DI Package
00618029720801
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |