SenSura Mio 11750
GUDID 05708932749947
Coloplast A/S
Colostomy irrigation sleeve| Primary Device ID | 05708932749947 |
| NIH Device Record Key | bcb45901-ab19-4288-a090-ab5a4e9f5684 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SenSura Mio |
| Version Model Number | 11750 |
| Catalog Number | 11750 |
| Company DUNS | 305524696 |
| Company Name | Coloplast A/S |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932749947 [Package] Contains: 05708932749961 Package: Shipper Box [10 Units] In Commercial Distribution |
| GS1 | 05708932749954 [Unit of Use] |
| GS1 | 05708932749961 [Primary] |
FDA Product Code
| EXD | Irrigator, ostomy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-21 |
| Device Publish Date | 2023-11-13 |
On-Brand Devices [SenSura Mio]
Trademark Results [SenSura Mio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENSURA MIO 79139969 4590839 Live/Registered |
Coloplast A/S 2013-09-16 |
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