New Image 19004

GUDID 20610075036220

Colostomy/Ileostomy Kit, FlexWear

HOLLISTER INCORPORATED

Intestinal ostomy bag/support kit

• Primary Device ID: 20610075036220
• NIH Device Record Key: a67b7ecd-4e8f-4905-867e-38b907c03805
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: New Image
• Version Model Number: 19004
• Catalog Number: 19004
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com

Device Dimensions

• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter
• Lumen/Inner Diameter: 57 Millimeter
• Lumen/Inner Diameter: 70 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075115181 [Unit of Use]
GS1	10610075114044 [Primary]
GS1	20610075036220 [Package]; Contains: 10610075114044; Package: CAS [12 Units]; In Commercial Distribution

FDA Product Code

• PQE: Ostomy care kit

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: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [New Image]

• 10610075115041: Two-Piece Mini Drainable Pre-sized Pouch, with Filter, Lock 'n Roll closure, Transparent, 70 mm,
• 20610075114140: Sterile Kit with Drainable Pouch, Clamp Closure, Loop Ostomy Bridge
• 20610075114119: Sterile Kit with Drainable Pouch, Lock 'n Roll Closure, Loop Ostomy Bridge
• 20610075114089: Non-sterile Kit with Drainable Pouch, Clamp Closure, Loop Ostomy Bridge
• 20610075114058: Non-sterile Kit with Drainable Pouch, Lock 'n Roll Closure, Loop Ostomy Bridge
• 20610075198638: Urostomy Kit, Flextend
• 20610075198621: Colostomy/Ileostomy Kit, FlexWear
• 20610075198614: Colostomy/Ileostomy Kit, FlexWear
• 20610075186321: Urostomy Kit, FormaFlex
• 20610075186307: Urostomy Kit, FormaFlex
• 20610075186284: Colostomy/Ileostomy Kit,FormaFlex
• 20610075186260: Colostomy/Ileostomy Kit,FormaFlex
• 20610075036572: Urostomy Kit, Flextend
• 20610075036466: Colostomy/Ileostomy Kit,FlexWear
• 20610075036244: Colostomy/Ileostomy Kit,FlexWear
• 20610075132342: Urostomy Kit, Flextend
• 20610075036282: Colostomy/Ileostomy Kit, FlexWear
• 20610075036206: Colostomy/Ileostomy Kit, FlexWear
• 20610075114744: 2-Piece Drainable Ostomy Pouch with Soft Tap
• 20610075036565: Urostomy Kit, Flextend
• 20610075036558: Urostomy Kit, Flextend
• 20610075036534: Urostomy Kit, Flextend
• 20610075036527: Urostomy Kit, Flextend
• 20610075036503: Colostomy/Ileostomy Kit,FlexWear
• 20610075036473: Colostomy/Ileostomy Kit,FlexWear
• 20610075036268: Colostomy/Ileostomy Kit,FlexWear
• 20610075036251: Colostomy/Ileostomy Kit,FlexWear
• 20610075036404: Colostomy/Ileostomy Kit, FlexWear
• 20610075036299: Colostomy/Ileostomy Kit, FlexWear
• 20610075036220: Colostomy/Ileostomy Kit, FlexWear
• 20610075036213: Colostomy/Ileostomy Kit, FlexWear
• 20610075187977: 2-Piece Urostomy Pouch
• 20610075187960: 2-Piece Urostomy Pouch
• 20610075187953: 2-Piece Urostomy Pouch
• 20610075187946: 2-Piece Urostomy Pouch
• 20610075187939: 2-Piece Urostomy Pouch
• 20610075187922: 2-Piece Urostomy Pouch
• 20610075187915: 2-Piece Urostomy Pouch
• 20610075187908: 2-Piece Urostomy Pouch
• 20610075187892: 2-Piece Urostomy Pouch
• 20610075184143: 2-Piece Urostomy Pouch
• 20610075184136: 2-Piece Urostomy Pouch
• 20610075184129: 2-Piece Urostomy Pouch
• 20610075184044: 2-Piece Urostomy Pouch
• 20610075184037: 2-Piece Urostomy Pouch
• 20610075184020: 2-Piece Urostomy Pouch
• 20610075182040: 2-Piece Drainable Ostomy Pouch
• 20610075182033: 2-Piece Drainable Ostomy Pouch
• 20610075182026: 2-Piece Drainable Ostomy Pouch
• 20610075181944: 2-Piece Drainable Ostomy Pouch