Exacta™ 680124/A

GUDID 20884450321038

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20884450321038
• NIH Device Record Key: a4c7bf40-780e-45d6-9725-696e64493fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exacta™
• Version Model Number: 10884450321031
• Catalog Number: 680124/A
• 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	00884450321034 [Unit of Use]
GS1	10884450321031 [Primary]
GS1	20884450321038 [Package]; Contains: 10884450321031; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2021-02-16

On-Brand Devices [Exacta™]

• 20884450321045: 10884450321048
• 20884450321052: 10884450321055
• 20884450389991: 10884450389994
• 20884450321069: 10884450321062
• 20884450321038: 10884450321031