AMSure ® Foley Catheters Tray AS89318H

GUDID 40704411014875

2000 mL Drainage Bag Hydrophilic Latex Foley Catheter 5 cc Balloon 18 Fr.

AMSINO INTERNATIONAL, INC.

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

• Primary Device ID: 40704411014875
• NIH Device Record Key: 5b8981ce-acc0-43bd-ae26-02956e4d28d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure ® Foley Catheters Tray
• Version Model Number: 1
• Catalog Number: AS89318H
• 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	10704411014874 [Primary]
GS1	40704411014875 [Package]; Contains: 10704411014874; Package: case [10 Units]; Discontinued: 2022-03-08; Not in Commercial Distribution

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: 2022-04-12
• Device Publish Date: 2022-04-04

On-Brand Devices [AMSure ® Foley Catheters Tray]

• 40704411014875: 2000 mL Drainage Bag Hydrophilic Latex Foley Catheter 5 cc Balloon 18 Fr.
• 10704411014867: 2000 mL Drainage Bag Hydrophilic Latex Foley Catheter 5 cc Balloon 16Fr.
• 40704411014851: 2000 mL Drainage Bag Hydrophilic Latex Foley Catheter 5 cc Balloon 14Fr.
• 40704411014691: 400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 18
• 40704411014684: 400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 16
• 40704411014677: 400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 14
• 40704411014660: 400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter 5 cc Balloo
• 40704411014653: 400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter 5 cc Balloo
• 40704411014646: 400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter 5 cc Balloo