Duns Number:942667882
Device Description: PPC-101 Clinical Model/U.V. Filter System (Specimen Collector)CCH Part No. 400151
Catalog Number
400151
Brand Name
Colonic Lavage System
Version/Model Number
PPC-101 Clinical Specimen Collector
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
K942867,K942867
Product Code
KPL
Product Code Name
Colonic Irrigation System
Public Device Record Key
904eeb41-f8a9-4ecd-9348-4d71e4b031dc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
B424400151
Quantity per Package
1
Contains DI Package
B4244001510
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Wood Crate
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |