Safedraw™ 682142/B

GUDID 20884450360594

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Invasive blood pressure transducer set

• Primary Device ID: 20884450360594
• NIH Device Record Key: 840147dc-3eb5-4a15-924a-fd6fefe03ec3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safedraw™
• Version Model Number: 10884450360597
• Catalog Number: 682142/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	00884450360590 [Unit of Use]
GS1	10884450360597 [Primary]
GS1	20884450360594 [Package]; Contains: 10884450360597; Package: [5 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: 2020-10-14
• Device Publish Date: 2020-10-06

On-Brand Devices [Safedraw™]

• 20884450388710: 10884450388713
• 20884450372535: 10884450372538
• 20884450372948: 10884450372941
• 20884450372511: 10884450372514
• 20884450481114: 10884450481117
• 20884450360594: 10884450360597
• 20884450544154: 10884450544157
• 20884450372788: 10884450372781
• 20884450409019: 10884450409012
• 20884450385108: 10884450385101
• 20884450384804: 10884450384807
• 20884450372801: 10884450372804
• 20884450360600: 10884450360603
• 20884450327665: 10884450327668
• 20884450327054: 10884450327057
• 20884450326613: 10884450326616
• 20884450326606: 10884450326609
• 20884450326590: 10884450326593
• 20884450326583: 10884450326586
• 20884450326446: 10884450326449
• 20884450326439: 10884450326432
• 20884450326422: 10884450326425
• 20884450326415: 10884450326418
• 20884450621152: 10884450621155
• 20884450619296: 10884450619299