AMSure® Pre-Connected Urethral Tray AS89216K

GUDID 40704411007532

AMSure® Pre-Connected Urethral Tray 16 Fr. Red Rubber Urethral Catheter Pre-Connected to Drainage Bag CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 1200 mL Drainage Bag with Pre-Connected 16 Fr. Red Rubber Urethral Catheter 1 each CSR Wrap 1 each Waterproof Absorbent Underpad 1 pair Pre-Cuffed Nitrile Gloves 1 each Fenestrated Drape 1 pack Package Sterile Lubricating Jelly 1 each 2 oz Specimen Container with ID Label NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)

AMSINO INTERNATIONAL, INC.

Intermittent urethral catheterization kit

• Primary Device ID: 40704411007532
• NIH Device Record Key: 9281e3a9-e169-4dce-8a4b-4968307e577d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Pre-Connected Urethral Tray
• Version Model Number: 1
• Catalog Number: AS89216K
• 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: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411007531 [Primary]
GS1	40704411007532 [Package]; Contains: 10704411007531; 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: 2018-04-28

On-Brand Devices [AMSure® Pre-Connected Urethral Tray]

• 40704411007549: AMSure® Pre-Connected Urethral Tray 14 Fr. Red Rubber Urethral Catheter Pre-Connected to Draina
• 40704411007532: AMSure® Pre-Connected Urethral Tray 16 Fr. Red Rubber Urethral Catheter Pre-Connected to Draina
• 40704411003817: AMSure® Pre-Connected Urethral Tray Red Rubber Urethral Catheter Pre-Connected to Drainage Bag.