FDA UDI
In Commercial Distribution
🇺🇸 United States
Areza Medical
DI: 00810147400263
·
Model: COPOV10
·
ADVANCED MEDICAL ASSOCIATES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
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Basic Information
- Brand Name
- Areza Medical
- Primary DI
- 00810147400263
- Version / Model
- COPOV10
- Catalog Number
- COPOV10
- Company Name
- ADVANCED MEDICAL ASSOCIATES, LLC
- Labeler DUNS
- 047724226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-10-26
- Public Version
- 1
- Public Version Date
- 2024-11-04
- Public Version Status
- New
- Public Device Record Key
- 388aec65-bb27-405c-9da0-81bd123397c4
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FON | Bag, Drainage, With Adhesive, Ostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62525 | Intestinal ostomy bag/support kit | A collection of devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). It includes not only the intestinal ostomy bag and a base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810147400270 | GS1 | Inner case | 10 | In Commercial Distribution | |
| Primary | 00810147400263 | GS1 | ||||
| Package | 00810147400287 | GS1 | Case | 30 | In Commercial Distribution | |
| Unit of Use | 00810147400256 | GS1 |
Customer Contacts
- Phone
- (214) 356-8716
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place. Avoid excessive heat