FDA UDI
In Commercial Distribution
🇺🇸 United States
ESTEEM
DI: 00768455204250
·
Model: 423676
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
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Basic Information
- Brand Name
- ESTEEM
- Primary DI
- 00768455204250
- Version / Model
- 423676
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2024-03-20
- Public Version
- 1
- Public Version Date
- 2024-03-28
- Public Version Status
- New
- Public Device Record Key
- 48fae904-5cef-4d93-86ca-242987946dc0
Device Description
N/A
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 |
|---|---|---|---|---|
| EZQ | Pouch, colostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31066 | One-piece intestinal ostomy bag, closed-ended | A plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10768455204257 | GS1 | 8 | In Commercial Distribution | ||
| Primary | 00768455204250 | GS1 | ||||
| Unit of Use | 00768455221592 | GS1 |
Customer Contacts
- Phone
- +18004228811
- [email protected]