NOVA

GUDID 26945040104357

Pulse Oximeter

Contec Medical Systems Co., Ltd.

Pulse oximeter, battery-powered

• Primary Device ID: 26945040104357
• NIH Device Record Key: 123f3473-7fd4-4bda-8ed7-7d95437d843c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA
• Version Model Number: PO-301
• Company DUNS: 529606295
• Company Name: Contec Medical Systems Co., Ltd.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945040104353 [Primary]
GS1	16945040104350 [Package]; Contains: 06945040104353; Package: case [2 Units]; In Commercial Distribution
GS1	26945040104357 [Package]; Contains: 16945040104350; Package: Carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082641

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: 2018-03-29
• Device Publish Date: 2017-06-07

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