AquaFlate 253

GUDID 50851809002499

AquaFlate 3.5mL Pre-Filled Sterile Water Syringe

HR PHARMACEUTICALS INC.

Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water Device-irrigation sterile water

• Primary Device ID: 50851809002499
• NIH Device Record Key: f3af1100-c4f9-43d6-b3c0-88fd2bb14a15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaFlate
• Version Model Number: 253
• Catalog Number: 253
• Company DUNS: 828918164
• Company Name: HR PHARMACEUTICALS 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

Customer Support Contacts

• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851809002494 [Primary]
GS1	50851809002499 [Package]; Contains: 00851809002494; Package: Case [400 Units]; In Commercial Distribution

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: 2023-05-29
• Device Publish Date: 2023-05-19

On-Brand Devices [AquaFlate]

• 50851809002871: AquaFlate 5mL Pre-Filled Sterile Water Syringe
• 50851809002512: AquaFlate 10mL Pre-Filled Sterile Water Syringe
• 50851809002499: AquaFlate 3.5mL Pre-Filled Sterile Water Syringe
• 50850025153985: AquaFlate 30mL Wide Pre-Filled Sterile Water Syringe
• 50850025153978: AquaFlate 10mL Wide Pre-Filled Sterile Water Syringe