Duns Number:942667882
Device Description: Bulb Style Large Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, C Bulb Style Large Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 924448
Catalog Number
924448
Brand Name
Colonic Irrigation Kit
Version/Model Number
SP01 Large Bulb 1448
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
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
K000388,K000388
Product Code
KPL
Product Code Name
Colonic Irrigation System
Public Device Record Key
17d4bd4a-8eb7-47e2-bbde-f4c9cce06afe
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
B424924448
Quantity per Package
1
Contains DI Package
B4249244480
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Plastic Bag
| 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 |