Duns Number:047025993
Device Description: Nosey Dysphagia Cup
Catalog Number
-
Brand Name
Vive
Version/Model Number
LVA2099GRY
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
0f1faf0d-f7a3-45b2-a312-ae0eb7524b41
Public Version Date
December 02, 2021
Public Version Number
1
DI Record Publish Date
November 24, 2021
Package DI Number
10810041988116
Quantity per Package
32
Contains DI Package
00810041988119
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 |