FDA UDI
In Commercial Distribution
🇺🇸 United States
NATURA
DI: 00768455104062
·
Model: 401919
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NATURA
- Primary DI
- 00768455104062
- Version / Model
- 401919
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-29
- Public Version
- 1
- Public Version Date
- 2022-10-07
- Public Version Status
- New
- Public Device Record Key
- bf160e4a-ec5f-4e08-9e26-9b7625262aa7
Device Description
Visi-Flow® Irrigation Adapter Faceplate 2 3/4"
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 |
|---|---|---|---|---|
| EZS | APPLIANCE, COLOSTOMY, DISPOSABLE | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60968 | Ostomy appliance ring/belt | A device consisting of a ring/plate and an adjustable and/or elastic belt intended to secure an ostomy appliance [e.g., bag, irrigation sleeve] (not included) to a patient’s stoma (e.g., in the intestine/colon) during use. The appliance is attached to the ring, which is attached to the belt worn by the patient. The device is typically made of synthetic polymer materials and is intended for use in the home and healthcare facility. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10768455104069 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00768455104062 | GS1 |
Customer Contacts
- Phone
- +18004228811
- [email protected]