Duns Number:329769991
Device Description: MasterScreen Paed
Catalog Number
171500
Brand Name
Jaeger
Version/Model Number
171500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 22, 2019
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCM
Product Code Name
Plethysmograph, Pressure
Public Device Record Key
eaa62293-f11c-4c65-986d-5bb632490906
Public Version Date
March 16, 2021
Public Version Number
5
DI Record Publish Date
August 03, 2016
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 | 76 |
2 | A medical device with a moderate to high risk that requires special controls. | 416 |