FDA UDI
In Commercial Distribution
🇺🇸 United States
FLEXI-SEAL
DI: 00768455207114
·
Model: 422291
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- FLEXI-SEAL
- Primary DI
- 00768455207114
- Version / Model
- 422291
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-14
- Public Version
- 2
- Public Version Date
- 2023-04-21
- Public Version Status
- Update
- Public Device Record Key
- 8e02bb22-7f9b-4c12-bc80-83ab4925bf1f
Device Description
Flexi-Seal™ Privacy FMS Collection Bags With Filter For Protect Plus Only
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 |
|---|---|---|---|---|
| 47038 | Faecal incontinence collector, catheterization | A receptacle intended to be used for the collection of liquid or semi-liquid stool (faeces) from a patient who is unable to control stool discharge. It consists of a faecal collection bag/pouch, a dedicated catheter intended to be attached to the bag proximally and inserted into the rectum distally, and adaptors/connectors. It is made of soft plastic material and may also include a drainage port and a syringe to drain faecal matter and/or to deliver medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00768455157174 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00768455207114 | GS1 | ||||
| Package | 10768455157171 | GS1 | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +18004228811
- [email protected]