Duns Number:341625331
Device Description: Set of ten Pneumotachograph tubes, single-patient use, accessory to SpiroPro
Catalog Number
-
Brand Name
P-Rohr Set SpiroPro
Version/Model Number
P-Rohr Set SpiroPro
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 16, 2021
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K031515,K092324
Product Code
BTY
Product Code Name
Calculator, Predicted Values, Pulmonary Function
Public Device Record Key
8cd4a924-2a28-425c-a55c-970832069aa9
Public Version Date
March 08, 2022
Public Version Number
7
DI Record Publish Date
July 29, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |