Duns Number:020275145
Device Description: Pulmonary Function Test Kit I, VBMax 36s with White Foam Nose Clip and Rubber Mouthpiece
Catalog Number
187126
Brand Name
PFT Kit I, VBMax 36s
Version/Model Number
PFT Kit I, VBMax 36s - 187126
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
b06478ea-721b-4756-969e-4a9dd183f02f
Public Version Date
June 03, 2021
Public Version Number
1
DI Record Publish Date
May 26, 2021
Package DI Number
00817081026924
Quantity per Package
100
Contains DI Package
00817081026917
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 |