Duns Number:076916246
Device Description: Invacare Jasmine Full-Body Lift
Catalog Number
JASMINE
Brand Name
Invacare Jasmine Full-Body Lift
Version/Model Number
JASMINE
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
FSA
Product Code Name
LIFT, PATIENT, NON-AC-POWERED
Public Device Record Key
d33c07d9-19bd-4190-8d5f-b24788bc38e8
Public Version Date
June 18, 2019
Public Version Number
1
DI Record Publish Date
June 10, 2019
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 | 136 |
2 | A medical device with a moderate to high risk that requires special controls. | 273 |