Duns Number:198227881
Device Description: Spirometry Pressure Tube and Handle (for Welch Allyn CP 150 with Spirometry and CPWS 5)
Catalog Number
410370
Brand Name
Welch Allyn, Inc.
Version/Model Number
901006
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
K082478
Product Code
BZG
Product Code Name
SPIROMETER, DIAGNOSTIC
Public Device Record Key
210dfbd3-52d2-4dce-8235-0d08eaf6cf29
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
November 06, 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 |