P23XL™ 682084/A

GUDID 20884450323186

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

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• Primary Device ID: 20884450323186
• NIH Device Record Key: fbdef20c-ee5b-4a10-a973-abc2324b6def
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P23XL™
• Version Model Number: 10884450323189
• Catalog Number: 682084/A
• Company DUNS: 595138793
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450323182 [Unit of Use]
GS1	10884450323189 [Primary]
GS1	20884450323186 [Package]; Contains: 10884450323189; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• DXO: TRANSDUCER, PRESSURE, CATHETER TIP

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-12-13
• Device Publish Date: 2018-11-27

Devices Manufactured by ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

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• 10884450330798 - Merit Medical®: 2022-09-28
• 20884450321502 - Careflow™: 2022-09-28
• 20884450387751 - Merit Medical®: 2022-06-24
• 20884450385160 - Meritrans DTXPlus®: 2022-06-16
• 20884450372085 - Merit Medical®: 2022-05-04