FDA UDI
In Commercial Distribution
🇺🇸 United States
Assura
DI: 00762123021392
·
Model: 12836
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- Assura
- Primary DI
- 00762123021392
- Version / Model
- 12836
- Catalog Number
- 12836
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 3
- Public Version Date
- 2024-04-17
- Public Version Status
- Update
- Public Device Record Key
- 5da32d0e-54fc-4ff4-ad53-4d6ec9cd5562
Device Description
Assura Irrigation Sleeves, 2-piece
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|
| 58889 | Colostomy irrigation sleeve | A non-sterile, soft plastic, open-ended cylinder intended for use during colostomy irrigation to funnel the resultant washout fluid into a sanitary collection receptacle (e.g., a toilet). It is typically attached to a plastic flange placed around the colostomy stoma and held in place by a waist belt. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00762123021392 | GS1 | ||||
| Package | 00762123021408 | GS1 | Shipper Box | 20 | In Commercial Distribution | |
| Unit of Use | 05708932681223 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 60 | Millimeter | |
| Device Size Text, specify | Coupling Size Diameter - in 2 3/8 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.