Duns Number:020275145
Device Description: Chart Paper, Thermal, for Cosmed Pony FX Spirometer
Catalog Number
140600
Brand Name
Chart Paper, Thermal, for Cosmed Pony FX Spirometer
Version/Model Number
Chart Paper, Thermal - 140600
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
Yes
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
DSF
Product Code Name
Recorder, Paper Chart
Public Device Record Key
56c6d23f-4228-4d41-a269-5eaab1c8407f
Public Version Date
March 31, 2020
Public Version Number
1
DI Record Publish Date
March 23, 2020
Package DI Number
00817081025699
Quantity per Package
10
Contains DI Package
00817081025682
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Roll
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |