acurio

GUDID 16972382160225

XIAMEN ACURIO INSTRUMENT CO.,LTD

Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 16972382160225
• NIH Device Record Key: d9655ebd-794c-42dd-8575-38a8f3e5a4e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: acurio
• Version Model Number: AS-301
• Company DUNS: 544491528
• Company Name: XIAMEN ACURIO INSTRUMENT CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	06972382160211 [Primary]
GS1	16972382160225 [Package]; Contains: 06972382160211; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180685

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-08
• Device Publish Date: 2020-06-30

On-Brand Devices [acurio]

• 16972382160188: AS-302
• 16972382160225: AS-301
• 16972382160256: AS-302