AEON

GUDID 36947832500108

SHENZHEN AEON TECHNOLOGY CO., LTD.

Pulse oximeter, battery-powered

• Primary Device ID: 36947832500108
• NIH Device Record Key: 86ebb829-fde6-444e-ac2a-62fc7ca5c57e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEON
• Version Model Number: A310L
• Company DUNS: 529372064
• Company Name: SHENZHEN AEON TECHNOLOGY 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	06947832500084 [Primary]
GS1	36947832500108 [Package]; Contains: 06947832500084; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190869

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: 2019-09-26
• Device Publish Date: 2019-09-18

On-Brand Devices [AEON]

• 06947832500282: A200
• 06947832500138: A201
• 36947832500092: A201
• 36947832500030: A310
• 36947832500375: A330N
• 36947832500368: A330
• 36947832500351: A320
• 36947832500306: A350
• 36947832500122: A340L
• 36947832500115: A340
• 36947832500108: A310L
• 36947832500085: A310
• 46947832500372: A340
• 36947832500429: A330B
• 36947832500399: A310B
• 16947832500470: A340B
• 46947832500099: A340L