Safe-Cam Connecting Cable Assembly SC-C

GUDID M710SCC0

BIOTEX, INC.

Rigid non-bladed video intubation laryngoscope

• Primary Device ID: M710SCC0
• NIH Device Record Key: aff27f49-b3b8-4e96-abb8-64385e368ffb
• Commercial Distribution Discontinuation: 2020-02-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Safe-Cam Connecting Cable Assembly
• Version Model Number: 033-6500
• Catalog Number: SC-C
• Company DUNS: 969792050
• Company Name: BIOTEX, INC.
• 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: 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

• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 540 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M710SCC0 [Primary]

FDA Product Code

• CCW: Laryngoscope, Rigid

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: 2020-03-05
• Device Publish Date: 2018-07-25

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