AMSure ® Hydrophilic Latex Foley Catheters

GUDID 40704411008980

Hydrophilic Latex Foley Catheters, 22FR, 5cc.

AMSINO INTERNATIONAL, INC.

Ureteral catheter

• Primary Device ID: 40704411008980
• NIH Device Record Key: d21c1872-7d1c-4026-a606-a6fcdae6ce5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure ® Hydrophilic Latex Foley Catheters
• Version Model Number: 1
• 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	10704411008989 [Primary]
GS1	40704411008980 [Package]; Contains: 10704411008989; Package: case [200 Units]; Discontinued: 2021-12-25; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091699

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

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: 2022-01-17
• Device Publish Date: 2022-01-07

On-Brand Devices [AMSure ® Hydrophilic Latex Foley Catheters]

• 40704411009642: Hydrophilic Latex Foley Catheters, 14FR, 30cc.
• 40704411009086: Hydrophilic Latex Foley Catheters, 28FR, 30cc.
• 40704411009079: Hydrophilic Latex Foley Catheters, 26FR, 30cc.
• 40704411009062: Hydrophilic Latex Foley Catheters, 24FR, 30cc.
• 40704411009055: Hydrophilic Latex Foley Catheters, 22FR, 30cc.
• 40704411009048: Hydrophilic Latex Foley Catheters, 20FR, 30cc.
• 40704411009031: Hydrophilic Latex Foley Catheters, 18FR, 30cc.
• 40704411009024: Hydrophilic Latex Foley Catheters, 16FR, 30cc.
• 40704411009017: Hydrophilic Latex Foley Catheters, 28FR, 5cc.
• 40704411009000: Hydrophilic Latex Foley Catheters, 26FR, 5cc.
• 40704411008997: Hydrophilic Latex Foley Catheters, 24FR, 5cc.
• 40704411008980: Hydrophilic Latex Foley Catheters, 22FR, 5cc.
• 40704411008973: Hydrophilic Latex Foley Catheters, 20FR, 5cc.
• 40704411008966: Hydrophilic Latex Foley Catheters, 18FR, 5cc.
• 40704411008959: Hydrophilic Latex Foley Catheters, 16FR, 5cc.
• 40704411008942: Hydrophilic Latex Foley Catheters, 14FR, 5cc.
• 40704411008935: Hydrophilic Latex Foley Catheters, 12FR, 5cc.
• 40704411008928: Hydrophilic Latex Foley Catheters, 10FR., 3cc.
• 10704411008910: Hydrophilic Latex Foley Catheters, 8FR., 3cc.