Micro C Medical Imaging System, M01 Foot Pedal

GUDID 00860001123432

Oxos Medical, Inc.

Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical

• Primary Device ID: 00860001123432
• NIH Device Record Key: 7b05e4d2-1779-430c-9419-b595d2de6b22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro C Medical Imaging System, M01 Foot Pedal
• Version Model Number: ACSY-P036
• Company DUNS: 080323883
• Company Name: Oxos Medical, Inc.
• 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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001123432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212654

FDA Product Code

• IZL: System, X-Ray, Mobile

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: 2022-03-24
• Device Publish Date: 2022-03-16

Devices Manufactured by Oxos Medical, Inc.

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• 00860001123456 - Micro C Medical Imaging System, Point of Care Cart Cassette Holder: 2022-06-21
• 00860001123463 - Micro C Medical Imaging System, Emitter Tripod: 2022-06-21
• 00860001123487 - Micro C Medical Imaging System, Weight Bearing Foot and Ankle System: 2022-06-21
• 00860001123449 - Micro C Medical Imaging System, Point of Care Cart, M01: 2022-04-21
• 00860001123432 - Micro C Medical Imaging System, M01 Foot Pedal: 2022-03-24
• 00860001123432 - Micro C Medical Imaging System, M01 Foot Pedal: 2022-03-24
• 00860001123401 - Micro C Medical Imaging System, M01: 2021-03-16