DEVICE: Peristeen (05708932544528)
Device Identifier (DI) Information
Peristeen
29129
In Commercial Distribution
29129
Coloplast A/S
29129
In Commercial Distribution
29129
Coloplast A/S
Peristeen Transanal Irrigation. System without a catheter. 1 control unit, 1 water bag, 2 straps, 1 tube, 1 storage case. Non sterile. Rx Only.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| No | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 45510 | Manual rectal irrigation system |
A portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. It typically consists of a control unit that regulates the air/water balance and includes a manually-operated hand pump to propel the water, a container for the water (e.g., a plastic bag), and a rectal catheter to channel the water. It is intended for use in the home and healthcare facility. This is a reusable device.
|
Active | false |
| 46204 | Rectal irrigation system fluid container |
A receptacle that is a component of a rectal irrigation system and designed to hold the water used for irrigation. It is typically a closed container (e.g., a plastic bag) with connecting ports for the system control unit. The irrigation is typically used to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. This is a reusable device.
|
Active | false |
| 46203 | Rectal irrigation system control unit |
An energy-producing regulator that is a component of a rectal irrigation system and designed to create the pressure required to propel the irrigation water into the rectum; it may also be used to inflate a catheter balloon. It typically includes a regulating device (e.g., a valve) used to control the air/water balance of the system, and a manually-operated hand pump. The irrigation is typically used to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
50daf695-5bf3-414b-9411-6d2825c05e58
March 19, 2024
3
September 20, 2016
March 19, 2024
3
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 05708932544535 | 6 | 05708932544528 | In Commercial Distribution | Shipper box |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)533-0464
healthcarecs@coloplast.com
healthcarecs@coloplast.com