AMSure® Add-A-Foley Catheter Tray AS89430

GUDID 10704411019732

"•FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •30 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"

AMSINO INTERNATIONAL, INC.

Urethral catheterization support kit, urinary drainage

• Primary Device ID: 10704411019732
• NIH Device Record Key: a19635be-12c3-4b5f-8932-a56a4d61043e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Add-A-Foley Catheter Tray
• Version Model Number: 1
• Catalog Number: AS89430
• 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	10704411019732 [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: 2025-07-09
• Device Publish Date: 2025-07-01

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

• 40704411007242: AMSure® Add-A-Foley Catheter Tray CONTENTS: One each 2000 mL Drainage bag with: Large anti-refl
• 40704411005293: AMSure® Add-A-Foley Catheter Tray CONTENTS; 1 2000mL Drainage bag, 1 Wrap, 1 Drape, 2 Nitrile G
• 40704411019757: "•FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestra
• 40704411019740: "•FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestra
• 10704411019732: "•FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestra
• 40704411019726: "•FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestra