Duns Number:047025993
Device Description: Lift Chair - Brown
Catalog Number
-
Brand Name
VIVE
Version/Model Number
LVA2017
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
INO
Product Code Name
Chair, Positioning, Electric
Public Device Record Key
9c9b1675-15d8-4a97-b242-ca67cfbee4c4
Public Version Date
June 05, 2019
Public Version Number
1
DI Record Publish Date
May 28, 2019
Package DI Number
10818323027966
Quantity per Package
1
Contains DI Package
00818323027969
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 | 480 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |