FDA UDI
In Commercial Distribution
🇺🇸 United States
SenSura Mio
DI: 05701780356077
·
Model: 19714
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
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Basic Information
- Brand Name
- SenSura Mio
- Primary DI
- 05701780356077
- Version / Model
- 19714
- Catalog Number
- 19714
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2025-04-25
- Public Version
- 1
- Public Version Date
- 2025-05-05
- Public Version Status
- New
- Public Device Record Key
- 89804396-15e9-42cb-b445-b4091edc4000
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
- No
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| EXB | Collector, ostomy | 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 | 05701780356084 | GS1 | Shipper Box | 12 | In Commercial Distribution | |
| Primary | 05701780356077 | GS1 | ||||
| Unit of Use | 05701780356091 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Base Plate Type Flat | ||
| Device Size Text, specify | Base Plate Max Cut Size - mm 45 | ||
| Device Size Text, specify | Descriptive Bag Size Mini | ||
| Device Size Text, specify | Base Plate Max Cut Size - in 1 3/4 | ||
| Device Size Text, specify | Base Plate Precut Start Hole Size - mm 15 | ||
| Device Size Text, specify | Base Plate Precut Start Hole Size - in 9/16 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- This way up.