AMSure ® Add-A-Foley Tray AS89800

GUDID 40704411014882

400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hanger Bed sheet clamp T-valve drainage outlet Air vent AMSafe® needleless sampling port 10 mL Pre-Filled Syringe with Sterile Water (China)

AMSINO INTERNATIONAL, INC.

Intermittent urethral drainage catheter, non-antimicrobial, single-use

• Primary Device ID: 40704411014882
• NIH Device Record Key: 09295006-1b80-48eb-aa80-b284b6585456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure ® Add-A-Foley Tray
• Version Model Number: 1
• Catalog Number: AS89800
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411014881 [Primary]
GS1	40704411014882 [Package]; Contains: 10704411014881; Package: case [10 Units]; Discontinued: 2022-03-08; Not 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-06
• Device Publish Date: 2022-03-29

On-Brand Devices [AMSure ® Add-A-Foley Tray]

• 40704411014882: 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hanger Bed sheet
• 10704411014706: 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hanger Bed sheet