Assura 12834

GUDID 00762123021361

Assura Irrigation Sleeves, 2-piece

Coloplast A/S

Colostomy irrigation sleeve

• Primary Device ID: 00762123021361
• NIH Device Record Key: 84168d2e-69d8-4c2d-b4e2-a5284e963f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assura
• Version Model Number: 12834
• Catalog Number: 12834
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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
• Email: healthcarecs@coloplast.com

Device Dimensions

• Lumen/Inner Diameter: 1.5625 Inch
• Lumen/Inner Diameter: 40 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00762123021354 [Package]; Contains: 05708932020213; Package: Retail box [5 Units]; In Commercial Distribution
GS1	00762123021361 [Package]; Contains: 00762123021354; Package: Shipper box [20 Units]; In Commercial Distribution
GS1	05708932020213 [Primary]

FDA Product Code

• EXD: Irrigator, ostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-14

On-Brand Devices [Assura]

• 00762123023464: Assura Irrigation Set. 1 Water bag, 1 Irrigation cone, 1 Belt plate, 2 Irrigation Set.
• 05708932651455: Assura Irrigation Set. 1 Water bag, 1 Irrigation cone, 1 Belt plate, 2 Irrigation Sleeves
• 00762123021392: Assura Irrigation Sleeves, 2-piece
• 00762123021378: Assura Irrigation Sleeves, 2-piece
• 00762123021361: Assura Irrigation Sleeves, 2-piece
• 05708932645836: Assura Irrigation, Face plate
• 00762123034095: Alterna Flex ostomy bag / Assura Flex ostomy bag / Alterna Ostomy pouch / Assura Ostomy pouc
• 00762123034019: Alterna Flex ostomy bag / Assura Flex ostomy bag / Alterna Ostomy pouch / Assura Ostomy pouc
• 00762123034071: Alterna Flex ostomy bag / Assura Flex ostomy bag / Alterna Ostomy Pouch / Assura Ostomy pouc
• 00762123034064: Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy Pouch / Assura Ostomy pouc
• 00762123034057: Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy Pouch / Assura Ostomy pouc
• 00762123033999: Alterna Ostomy pouch / Assura Ostomy pouch. 1-piece closed. Transparent. Midi. Midi. Base Pla
• 00762123033982: Alterna Ostomy pouch / Assura Ostomy pouch. 1-piece closed. Transparent. Midi. Midi. Base Pla
• 00762123033944: Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy Pouch / Assura Ostomy pouc
• 00762123033975: Alterna Ostomy Pouch / Assura Ostomy pouch. 1-piece closed. Transparent. Midi. Midi. Base Pla
• 00762123033937: Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy pouch / Assura Ostomy pouc
• 00762123033623: Alterna Protective Seal / Assura Protective Seal / Alterna ostomy pouch / Assura Ostomy pouc
• 00762123050071: 14512
• 00762123050057: 14511
• 00762123050026: 14419
• 00762123050002: 14416
• 00762123049983: 14413
• 00762123049747: 15879
• 00762123049648: 2845
• 00762123049426: 8116
• 00762123049402: 8115
• 00762123049389: 8114
• 00762123048528: 14717
• 00762123048504: 14222
• 00762123048269: 15983
• 00762123048221: 15982
• 00762123047767: 14298
• 00762123047743: 14297
• 00762123047729: 14296
• 00762123047705: 14295
• 00762123047682: 14294
• 00762123047668: 14293
• 00762123047644: 14292
• 00762123047620: 14291
• 00762123047606: 14283
• 00762123047583: 14282
• 00762123047569: 14281
• 00762123046616: 15986
• 00762123046593: 15976
• 00762123046579: 15956
• 00762123046555: 15985
• 00762123046531: 15975
• 00762123046517: 15955
• 00762123046494: 15984
• 00762123046470: 15974