Meritrans DTXPlus® 682035/B

GUDID 20884450371842

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Invasive blood pressure transducer set

• Primary Device ID: 20884450371842
• NIH Device Record Key: 86b6f83b-a89a-4925-bc30-0e28f25f24d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meritrans DTXPlus®
• Version Model Number: 10884450371845
• Catalog Number: 682035/B
• Company DUNS: 595138793
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Device Count: 5
• 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	00884450371848 [Unit of Use]
GS1	10884450371845 [Primary]
GS1	20884450371842 [Package]; Contains: 10884450371845; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935782

FDA Product Code

• DXN: System, measurement, blood-pressure, non-invasive

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: 2020-11-03
• Device Publish Date: 2020-10-26

On-Brand Devices [Meritrans DTXPlus®]

• 20884450323247: 10884450323240
• 20884450384187: 10884450384180
• 20884450435629: 10884450435622
• 20884450371750: 10884450371753
• 20884450323117: 10884450323110
• 20884450373006: 10884450373009
• 20884450463851: 10884450463854
• 20884450385061: 10884450385064
• 20884450482531: 10884450482534
• 20884450384248: 10884450384241
• 20884450371798: 10884450371791
• 20884450371842: 10884450371845
• 20884450371736: 10884450371739
• 20884450360822: 10884450360825
• 20884450360761: 10884450360764
• 20884450360709: 10884450360702
• 20884450360686: 10884450360689
• 20884450360532: 10884450360535
• 20884450328969: 10884450328962
• 20884450324114: 10884450324117
• 20884450323230: 10884450323233
• 20884450323131: 10884450323134
• 20884450323032: 10884450323035
• 20884450323025: 10884450323028
• 20884450322974: 10884450322977
• 20884450322943: 10884450322946
• 20884450322929: 10884450322922
• 20884450322561: 10884450322564
• 20884450322554: 10884450322557
• 20884450322547: 10884450322540
• 20884450371774: 10884450371777
• 20884450619289: 10884450619282
• 00884450323267: 10884450323264
• 20884450385160: 10884450385163
• 20884450360631: B