FDA UDI
In Commercial Distribution
🇺🇸 United States
Assura
DI: 05708932651448
·
Model: 12830
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Assura
- Primary DI
- 05708932651448
- Version / Model
- 12830
- Catalog Number
- 12830
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 00140d77-16e9-4926-9179-9fab19458a98
Device Description
Assura Irrigation Set. 1 Water bag, 1 Irrigation cone, 1 Belt plate, 2 Irrigation Sleeves
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| EXD | Irrigator, ostomy | Gastroenterology, Urology | 876.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58888 | Colostomy irrigation kit, reusable | A collection of non-sterile devices designed to wash out the colon through a colostomy site. It typically includes a container of fluid, tubing with a cone-shaped tip, or a soft and flexible catheter with a retention shield; it may include some disposables. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932651455 | GS1 | Shipper box | 12 | In Commercial Distribution | |
| Primary | 05708932651448 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Horisontal storage
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight