Santamedical

GUDID 16945040104480

Pulse Oximeter.Sports and aviation.OCH

Contec Medical Systems Co., Ltd.

Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 16945040104480
• NIH Device Record Key: 1f8cdfea-80ad-4b37-9c44-28b1d8ba0ac9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Santamedical
• Version Model Number: SM-165
• 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	06945040104483 [Primary]
GS1	16945040104480 [Package]; Contains: 06945040104483; Package: Carton [200 Units]; In Commercial Distribution

FDA Product Code

• OCH: Oximeter, Infrared, Sporting, Aviation

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: 2017-09-01

Devices Manufactured by Contec Medical Systems Co., Ltd.

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• 06945040106234 - CONTEC: 2022-01-17 Electronic Sphygmomanometer
• 06945040106258 - CONTEC: 2022-01-17 Electronic Sphygmomanometer
• 06945040104728 - CONCORD: 2021-11-10 Pulse Oximeter