Duns Number:305524696
Device Description: Peristeen Plus Transanal irrigation / Peristeen Plus Transanal Irrigation. System without Peristeen Plus Transanal irrigation / Peristeen Plus Transanal Irrigation. System without a catheter. 1 control unit; 1 water bag (incl. screw top); 2 straps; 1 tube.
Catalog Number
29152
Brand Name
Peristeen Plus
Version/Model Number
29152
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCE
Product Code Name
Enema kit
Public Device Record Key
b523bc57-afd8-405a-a4ad-79a12dce7421
Public Version Date
October 18, 2021
Public Version Number
1
DI Record Publish Date
October 08, 2021
Package DI Number
05708932732666
Quantity per Package
6
Contains DI Package
05708932732659
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |