PULSOX-300i

GUDID 04571237524189

KONICA MINOLTA, INC.

Pulse oximeter, battery-powered

• Primary Device ID: 04571237524189
• NIH Device Record Key: d1a2146c-38c6-4d2d-bc06-f28a1728c975
• Commercial Distribution Discontinuation: 2018-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PULSOX-300i
• Version Model Number: 1732311A
• Company DUNS: 691820126
• Company Name: KONICA MINOLTA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	04571237524189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053419

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: 4
• Public Version Date: 2019-02-08
• Device Publish Date: 2016-08-24

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