Pouchkins

GUDID 20610075037777

Premie One-Piece Ostomy Pouch – Flat Cut-to-Fit Barrier_15mm 5/8"

HOLLISTER INCORPORATED

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• Primary Device ID: 20610075037777
• NIH Device Record Key: 302af2b4-5e11-41f8-a101-48a38cfdd414
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pouchkins
• Version Model Number: 3777
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 15
• 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: false
• OTC Over-The-Counter: false

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
• 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

• Length: 4.5 Inch
• Length: 4.5 Inch
• Length: 4.5 Inch
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075037773 [Primary]
GS1	00610075082056 [Unit of Use]
GS1	20610075037777 [Package]; Contains: 00610075037773; Package: Case [24 Units]; In Commercial Distribution
GS1	30610075037774 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-01-01

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• 20610075037777: Premie One-Piece Ostomy Pouch – Flat Cut-to-Fit Barrier_15mm 5/8"
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• 10610075110497: 1-Piece Pediatric Drainable Ostomy Pouch, SoftFlex
• 20610075037746: Pediatric Ostomy Belt