FDA UDI
In Commercial Distribution
🇺🇸 United States
Peristeen Plus
DI: 05701780221474
·
Model: 29151
·
Coloplast A/S
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Peristeen Plus
- Primary DI
- 05701780221474
- Version / Model
- 29151
- Catalog Number
- 29151
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-01
- Public Version
- 1
- Public Version Date
- 2021-10-11
- Public Version Status
- New
- Public Device Record Key
- a995e4dc-040e-48cf-acd2-e3798fad205e
Device Description
Peristeen Plus Transanal irrigation / Peristeen Plus Transanal Irrigation. System without a catheter. 1 control unit1 water bag (incl. screw top)2 straps1 tube. (incl. toilet bag).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, gastrointestinal (and accessories) | Gastroenterology, Urology | 876.5980 | 2 |
| FCE | Enema kit | Gastroenterology, Urology | 876.5210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05701780221481 | GS1 | Retail Box | 1 | In Commercial Distribution | |
| Primary | 05701780221474 | GS1 | ||||
| Package | 05701780221498 | GS1 | Shipper Box | 6 | In Commercial Distribution |