Duns Number:020275145
Device Description: PFT Kit, ADInstruments Custom - disposable 35mm VBMax PFT filter, disposable Nose Clip, an PFT Kit, ADInstruments Custom - disposable 35mm VBMax PFT filter, disposable Nose Clip, and reusable mouth piece
Catalog Number
180005
Brand Name
PFT KIT, ADInstruments Custom
Version/Model Number
PFT KIT, ADInstruments Custom - 180005
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
93c827fb-a4f6-43c3-ba8e-cc93b5c639b1
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 06, 2019
Package DI Number
00817081021622
Quantity per Package
100
Contains DI Package
00817081021615
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 |