Duns Number:393789540
Device Description: Pulmonary Function Testing Device, intended for measuring lung volumes by spirometry and H Pulmonary Function Testing Device, intended for measuring lung volumes by spirometry and Helium dilution
Catalog Number
10-SA-03-TA
Brand Name
TransAir3
Version/Model Number
TransAir3
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K953990
Product Code
BZC
Product Code Name
Calculator, Pulmonary Function Data
Public Device Record Key
63359a1c-23dc-4d5e-b3a0-2c39995388fa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |