Duns Number:080143399
Device Description: This keyguard specifically designed to work with 84 LAMP WFL vocabulary files on the PRiO- This keyguard specifically designed to work with 84 LAMP WFL vocabulary files on the PRiO-mini.
Catalog Number
-
Brand Name
PRiO-mini 84 Location Keyguard
Version/Model Number
17656
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILQ
Product Code Name
System, Communication, Powered
Public Device Record Key
82d46789-89a7-4a74-b74a-c198b524d594
Public Version Date
February 25, 2019
Public Version Number
1
DI Record Publish Date
January 25, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 198 |