Duns Number:355470923
Device Description: Provox Life BasePlate Adaptor is an accessory that allows attaching and detaching medical Provox Life BasePlate Adaptor is an accessory that allows attaching and detaching medical devices, e.g. an HME, with an ISO 15 mm standard connector to a Provox Life attachment. The adaptor is intended for single patient reuse.
Catalog Number
8057
Brand Name
Provox Life BasePlate Adaptor
Version/Model Number
8057
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"
-
For Single-Use
-
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
BYD
Product Code Name
Condenser, Heat And Moisture (Artificial Nose)
Public Device Record Key
349a87ae-78d9-45ed-95a9-dfb8121a5ea8
Public Version Date
July 20, 2022
Public Version Number
1
DI Record Publish Date
July 12, 2022
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 | 119 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 169 |