AMSure® Urethral Catheterization Tray AS870K

GUDID 40704411007600

AMSure® Urethral Catheterization Tray CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 14 Fr. Vinyl Catheter 1 each 1000 mL Outer Basin Tray 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 each 4 oz Specimen Cup NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)

AMSINO INTERNATIONAL, INC.

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• Primary Device ID: 40704411007600
• NIH Device Record Key: 867ee483-76af-4cf4-9928-a6c31203dc49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Urethral Catheterization Tray
• Version Model Number: 1
• Catalog Number: AS870K
• 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	10704411007609 [Primary]
GS1	40704411007600 [Package]; Contains: 10704411007609; 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: 2018-06-21

On-Brand Devices [AMSure® Urethral Catheterization Tray]

• 40704411007600: AMSure® Urethral Catheterization Tray CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 14 Fr. V
• 40704411007525: AMSure® Urethral Catheterization Tray 14Fr CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Red
• 40704411003800: AMSure® Urethral Catheterization Tray CONTENTS: 1 each Red Rubber Urethral Catheter, 1 each 100
• 40704411003794: AMSure® Urethral Catheterization Tray CONTENTS: 1 each Red Rubber Urethral Catheter, 1 each 100
• 40704411003787: AMSure® Urethral Catheterization Tray CONTENTS: 1 each Red Rubber Urethral Catheter, 1 each 100
• 40704411003770: AMSure® Urethral Catheterization Tray CONTENTS: 1 each 14Fr Vinyl Catheter, 1 each 1000mL Outer