FDA UDI
In Commercial Distribution
🇺🇸 United States
Peristeen Plus
DI: 05708932745239
·
Model: 29146
·
Coloplast A/S
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Peristeen Plus
- Primary DI
- 05708932745239
- Version / Model
- 29146
- Catalog Number
- 29146
- 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
- 71e834cf-28d2-4537-bcd3-ead4a18ecda0
Device Description
Peristeen Plus Transanal Irrigation / Peristeen Plus / Peristeen Plus Transanal irrigation. Tube. 2 tubes with turquoise connectors.
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 |
|---|---|---|---|---|
| 61651 | Rectal/colonic lavage support kit | A collection of non-sterile, noninvasive devices intended to be used in conjunction with a rectal and/or colonic irrigation system to support the introduction of an irrigation solution into the rectum/colon. It includes non-powered, supportive devices typically intended to assist introduction/securing of irrigation devices; it does not include a colonic/rectal irrigation nozzle/catheter. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932745253 | GS1 | Shipper Box | 10 | In Commercial Distribution | |
| Package | 05708932745246 | GS1 | Retail Box | 2 | In Commercial Distribution | |
| Primary | 05708932745239 | GS1 |