SimbR

GUDID 06945040105190

Pulse Oximeter

Contec Medical Systems Co., Ltd.

Pulse oximeter, battery-powered

• Primary Device ID: 06945040105190
• NIH Device Record Key: bf2691f2-341f-4e40-abd9-1d478ae66aaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimbR
• Version Model Number: DZ05-A1
• Company DUNS: 529606295
• Company Name: Contec Medical Systems Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	06945040105190 [Primary]

FDA Product Code

• PGJ: Oximeter, Wellness

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: 2020-04-30
• Device Publish Date: 2020-04-22

Devices Manufactured by Contec Medical Systems Co., Ltd.

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• 06945040106913 - CONTEC: 2024-06-03 Color Doppler Ultrasound Diagnostic System
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• 06945040105411 - CONTEC: 2022-11-08 Pocket Fetal Doppler