Duns Number:329769991
Device Description: MasterScreen Body/Diff
Catalog Number
V-175420
Brand Name
Jaeger
Version/Model Number
V-175420
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 21, 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
BZC
Product Code Name
Calculator, Pulmonary Function Data
Public Device Record Key
dc7b5ac4-d0bc-41e5-8271-e57d9824f4d4
Public Version Date
March 16, 2021
Public Version Number
5
DI Record Publish Date
August 02, 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 |