AMSure® Foley Insertion Tray AS880-02

GUDID 40704411008027

AMSure® Foley Insertion Tray CONTENTS: Color: Pantone 293c 1 each 1000mL Outer Basin Tray 1 each Prefilled 10cc Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 pack PVP Swabsticks (3)

AMSINO INTERNATIONAL, INC.

Intermittent urethral catheterization kit

• Primary Device ID: 40704411008027
• NIH Device Record Key: 9d24c2a2-af66-4a6a-93df-bb92e2bb8cf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Foley Insertion Tray
• Version Model Number: 1
• Catalog Number: AS880-02
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411008026 [Primary]
GS1	40704411008027 [Package]; Contains: 10704411008026; Package: case [20 Units]; In Commercial Distribution

FDA Product Code

• FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-28
• Device Publish Date: 2018-05-30

On-Brand Devices [AMSure® Foley Insertion Tray]

• 40704411008034: AMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray 1 each Prefilled 30cc Syr
• 40704411008027: AMSure® Foley Insertion Tray CONTENTS: Color: Pantone 293c 1 each 1000mL Outer Basin Tray 1 eac
• 10704411007623: AMSure® Foley Insertion Tray CONTENTS: 1 each 1000 mL Outer Basin Tray 1 each Prefilled 30 mL S
• 40704411007617: AMSure® Foley Insertion Tray CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 1000 mL Outer Bas
• 40704411002391: AMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray, 1 each Prefilled 30cc Sy
• 40704411002384: AMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray, 1 each Prefilled 10cc Sy