Duns Number:020275145
Device Description: Pulmonary Function Testing Kit A, Disposable, Qty 100, 30 MM O.D., w/ Foam Nose Clips
Catalog Number
181111
Brand Name
PFT Kit A
Version/Model Number
PFT Kit A, Disposable, 30 MM O.D. - 181111
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
K000654,K000654
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
db6cf651-a47d-492f-b39d-cb0d67a616ad
Public Version Date
June 30, 2020
Public Version Number
1
DI Record Publish Date
June 22, 2020
Package DI Number
00817081026702
Quantity per Package
100
Contains DI Package
00817081026696
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |