AMSure® 100% Silicone Foley Catheter AS41016S

GUDID 10704411001935

AMSure® 100% Silicone Foley Catheter Radiopaque

AMSINO INTERNATIONAL, INC.

Indwelling urethral drainage catheter

• Primary Device ID: 10704411001935
• NIH Device Record Key: aaac99cd-0e66-40fe-9073-507ad8103808
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® 100% Silicone Foley Catheter
• Version Model Number: 1
• Catalog Number: AS41016S
• 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	10704411001935 [Primary]
GS1	30704411001939 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	40704411001936 [Package]; Contains: 30704411001939; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082815

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 9
• Public Version Date: 2020-12-04
• Device Publish Date: 2016-09-23

On-Brand Devices [AMSure® 100% Silicone Foley Catheter]

• 10704411002161: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002154: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002147: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002130: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002123: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002116: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002109: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002093: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002086: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002079: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002062: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002055: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002048: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002031: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002024: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002017: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411002000: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001997: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001980: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001973: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001966: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001959: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001942: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001935: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001928: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001911: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001904: AMSure® 100% Silicone Foley Catheter Radiopaque
• 10704411001898: AMSure® 100% Silicone Foley Catheter Radiopaque