Duns Number:020275145
Device Description: PFT Kit A, Disposable, 48MM OD Filter w/ Blue Foam Nose Clip and Rubber Mouthpiece
Catalog Number
188413
Brand Name
PFT Kit A, Disposable, 48MM OD
Version/Model Number
PFT Kit A, Disposable, 48MM OD - 188413
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
36fc261b-4011-43da-b065-315bf2ed3b4d
Public Version Date
May 14, 2020
Public Version Number
1
DI Record Publish Date
May 06, 2020
Package DI Number
00817081026665
Quantity per Package
100
Contains DI Package
00817081026658
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 |