Duns Number:198227881
Device Description: Welch Allyn Diagnostic Cardiology Suite Spirometry; Software, Spirometer, USB cable, press Welch Allyn Diagnostic Cardiology Suite Spirometry; Software, Spirometer, USB cable, pressure tubing, handle, 4 pack of flow transducers, Calibration Syringe
Catalog Number
DCSS-CXA
Brand Name
Welch Allyn, Inc.
Version/Model Number
901128
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZG
Product Code Name
SPIROMETER, DIAGNOSTIC
Public Device Record Key
9126cf73-1d22-439c-9965-a1449b231445
Public Version Date
June 28, 2022
Public Version Number
5
DI Record Publish Date
September 25, 2019
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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |