FDA UDI
In Commercial Distribution
🇺🇸 United States
VISI-FLOW STOMA CONE
DI: 00768455107087
·
Model: 022736
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VISI-FLOW STOMA CONE
- Primary DI
- 00768455107087
- Version / Model
- 022736
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 7
- Public Version Date
- 2023-05-19
- Public Version Status
- Update
- Public Device Record Key
- b186f99d-0c80-485b-a774-407cbd0b0b3d
Device Description
Visi-Flow® Stoma Cone
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 31987 | Colostomy rod | A device that is placed through a loop of colon brought out through the abdominal wall to temporarily keep it from sliping back through the surgical opening during the loop colostomy procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00768455107087 | GS1 | ||||
| Package | 10768455107084 | GS1 | Case | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +18004228811
- [email protected]