AMSure® Silicone Coated Latex Foley Catheter AS42028

GUDID 10704411001706

AMSure® Silicone Coated Latex Foley Catheter

AMSINO INTERNATIONAL, INC.

Indwelling urethral drainage catheter

• Primary Device ID: 10704411001706
• NIH Device Record Key: 96e93bf1-ccf7-4c0f-a213-35b771315a5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Silicone Coated Latex Foley Catheter
• Version Model Number: 1
• Catalog Number: AS42028
• 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	10704411001706 [Primary]
GS1	30704411001700 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	40704411001707 [Package]; Contains: 30704411001700; 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® Silicone Coated Latex Foley Catheter]

• 10704411001775: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001768: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001751: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001744: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001737: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001720: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001713: AMSure® Silicone Coated Latex Foley Catheter content
• 10704411001706: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001690: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001683: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001676: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001669: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001652: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001645: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001638: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001621: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001614: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001607: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001591: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001584: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001577: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001560: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001553: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001546: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001539: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001522: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001515: AMSure® Silicone Coated Latex Foley Catheter
• 10704411001508: AMSure® Silicone Coated Latex Foley Catheter