SenSura Mio 12216

GUDID 05708932925488

Coloplast A/S

Multiple-piece intestinal ostomy bag, closed-ended

• Primary Device ID: 05708932925488
• NIH Device Record Key: 3fe8470d-9f04-4750-b52f-634cd50f92d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SenSura Mio
• Version Model Number: 12216
• Catalog Number: 12216
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com

Device Dimensions

• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 50 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932925488 [Package]; Contains: 05708932926508; Package: Shipper Box [12 Units]; In Commercial Distribution
GS1	05708932926508 [Primary]
GS1	05708932927529 [Unit of Use]

FDA Product Code

• EXB: COLLECTOR, 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: 2022-12-12
• Device Publish Date: 2022-12-02

On-Brand Devices [SenSura Mio]

• 05701780255103: SenSura Mio . 2-piece.
• 05701780254960: SenSura Mio . 2-piece open wide outlet. Transparent, Full-circle filter. XXL.
• 05708932925952: 10871
• 05708932925945: 10872
• 05708932925938: 10873
• 05708932925921: 10874
• 05708932925914: 10881
• 05708932925907: 10883
• 05708932925891: 10884
• 05708932925884: 10885
• 05708932925877: 10461
• 05708932925860: 10471
• 05708932925853: 10472
• 05708932925846: 10473
• 05708932925839: 10474
• 05708932925822: 10475
• 05708932925815: 10476
• 05708932925808: 10479
• 05708932925792: 10477
• 05708932925785: 10478
• 05708932925778: 10480
• 05708932925761: 10481
• 05708932925754: 10482
• 05708932925747: 10483
• 05708932925730: 10484
• 05708932925723: 10487
• 05708932925716: 10488
• 05708932925709: 10489
• 05708932925693: 10490
• 05708932925686: 10491
• 05708932925679: 10485
• 05708932925662: 10486
• 05708932925655: 10492
• 05708932925648: 10493
• 05708932925631: 10494
• 05708932925624: 10495
• 05708932925617: 10496
• 05708932925600: 10586
• 05708932925594: 11401
• 05708932925587: 11402
• 05708932925570: 11412
• 05708932925563: 11413
• 05708932925556: 11421
• 05708932925549: 11422
• 05708932925532: 11425
• 05708932925525: 11426
• 05708932925518: 12202
• 05708932925501: 12203
• 05708932925495: 12213
• 05708932925488: 12216