RadialFlo™ 682315/A

GUDID 20884450363953

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Arterial blood pressure catheter

• Primary Device ID: 20884450363953
• NIH Device Record Key: 1ef39c4d-b45b-463c-8df3-2c88cd865af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RadialFlo™
• Version Model Number: 10884450363956
• Catalog Number: 682315/A
• Company DUNS: 595138793
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450363959 [Unit of Use]
GS1	10884450363956 [Primary]
GS1	20884450363953 [Package]; Contains: 10884450363956; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• FOZ: Catheter, intravascular, therapeutic, short-term less than 30 days

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: 2021-10-11
• Device Publish Date: 2019-02-28

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

• 20884450628304 - Merit Medical®: 2024-12-16
• 20884450360631 - Meritrans DTXPlus®: 2024-09-16
• 10884450330750 - Merit Medical®: 2024-01-22
• 20884450387768 - Merit Medical®: 2023-05-04
• 20884450388161 - Merit Medical®: 2023-03-13
• 10884450330798 - Merit Medical®: 2022-09-28
• 20884450321502 - Careflow™: 2022-09-28
• 20884450387751 - Merit Medical®: 2022-06-24