AMSure® TUR/Bladder Irrigation Set Y-Type ABL402

GUDID 40704411005477

AMSure® TUR/Bladder Irrigation Set Y-Type 90" (2886 mm) Overall Length/0.27" (6.8 mm) I.D. Non-Pyrogenic

AMSINO INTERNATIONAL, INC.

Urological irrigation set

• Primary Device ID: 40704411005477
• NIH Device Record Key: ab6fdae7-763c-41f3-acfe-f8910b9558fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® TUR/Bladder Irrigation Set Y-Type
• Version Model Number: 1
• Catalog Number: ABL402
• 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	10704411005476 [Primary]
GS1	40704411005477 [Package]; Contains: 10704411005476; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• LJH: System, Irrigation, Urological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-04
• Device Publish Date: 2016-09-23

Devices Manufactured by AMSINO INTERNATIONAL, INC.

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• 40704411016602 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, 5mL, use only in flushing compatible intravenous administration sets and indwe
• 40704411016619 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, 10mL, use only in flushing compatible intravenous administration sets and indw
• 40704411016626 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 3mL, use only in flushing compatible intravenous administ
• 40704411016633 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 5mL, use only in flushing compatible intravenous administ
• 40704411016640 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 10mL, use only in flushing compatible intravenous adminis
• 40704411016244 - AMSafe ® I.V Administration Set 100'': 2023-08-28 For use with Spectrum, Flo-Gard 6201 and 6301 series pumps 100” (2.5m), 10 drops/mL, Slide and Roller Clamp, 1.2 Micron Filter
• 40704411016152 - AMSure ® Enteral Administration Kit: 2023-06-01 Enteral Administration Kit FOR USE WITH AMSure® ENTERAL FEEDING PUMP CONTENTS: -Enteral Feeding 500 mL Bag Pump Set with ENFit