Duns Number:020275145
Device Description: VBMax31 Disposable Pulmonary Function Testing Filter - Met-Test
Catalog Number
156713
Brand Name
VBMax31
Version/Model Number
VBMax31 - 156713
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"
Yes
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
04b16c8f-9460-4eb9-a44b-ecfd386afaea
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 25, 2017
Package DI Number
00817081021295
Quantity per Package
100
Contains DI Package
00817081021288
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 |