AMSure ® Add-A-Foley Tray AS89830

GUDID 10704411014706

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 30 mL Pre-Filled Syringe with Sterile Water (China)

AMSINO INTERNATIONAL, INC.

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

• Primary Device ID: 10704411014706
• NIH Device Record Key: 1141ba4d-3e5d-4555-9890-7bb2ffe47490
• Commercial Distribution Discontinuation: 2022-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AMSure ® Add-A-Foley Tray
• Version Model Number: 1
• Catalog Number: AS89830
• 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	10704411014706 [Primary]

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