SANTAMEDICAL

GUDID 10810053630010

XIAMEN ACURIO INSTRUMENT CO.,LTD

Pulse oximeter

• Primary Device ID: 10810053630010
• NIH Device Record Key: ad2f50f1-8fcc-4689-a95b-324abe689bea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SANTAMEDICAL
• Version Model Number: SM-ACLED150
• 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	00810053630013 [Primary]
GS1	10810053630010 [Package]; Contains: 00810053630013; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2020-06-01

On-Brand Devices [SANTAMEDICAL]

• 16972382160201: AS-301-L
• 10810053630010: SM-ACLED150