Duns Number:017840548
Device Description: Self-Recovery device to assist a fallen person moving themselves to a seated position afte Self-Recovery device to assist a fallen person moving themselves to a seated position after a non-injurious fall.Color: Midnight
Catalog Number
-
Brand Name
ResQUp
Version/Model Number
Midnight
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
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
c5f597de-299b-4a25-a7bd-9207f8e5fbd4
Public Version Date
December 17, 2021
Public Version Number
1
DI Record Publish Date
December 09, 2021
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 | 4 |