SenSura Mio 18777

GUDID 05701780292801

Coloplast A/S

One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended
Primary Device ID05701780292801
NIH Device Record Keyd56181b8-1f70-4da9-acdc-c949f036261e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSenSura Mio
Version Model Number18777
Catalog Number18777
Company DUNS305524696
Company NameColoplast A/S
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *This way up. Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS105701780288767 [Primary]
GS105701780292801 [Package]
Contains: 05701780288767
Package: Shipper Box [20 Units]
In Commercial Distribution
GS105701780295802 [Unit of Use]

FDA Product Code

EXBCollector, ostomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-18
Device Publish Date2024-03-08

On-Brand Devices [SenSura Mio]

05701780255103SenSura Mio . 2-piece.
05701780254960SenSura Mio . 2-piece open wide outlet. Transparent, Full-circle filter. XXL.
0570893292595210871
0570893292594510872
0570893292593810873
0570893292592110874
0570893292591410881
0570893292590710883
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0570893292585310472
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0570893292580810479
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Trademark Results [SenSura Mio]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SENSURA MIO
SENSURA MIO
79139969 4590839 Live/Registered
Coloplast A/S
2013-09-16

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