4Klear 4KL100

GUDID 00817613020819

4Klear Camera / Medical Recorder - Includes 9M Camera Cable

MED X CHANGE, INC.

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 00817613020819
• NIH Device Record Key: 15feab39-0106-4474-b4e1-d1d40feae821
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4Klear
• Version Model Number: 4KL100.9M
• Catalog Number: 4KL100
• Company DUNS: 051244569
• Company Name: MED X CHANGE, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817613020819 [Primary]

FDA Product Code

• KQM: Camera, Surgical And Accessories

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: 2019-05-10
• Device Publish Date: 2019-05-02

On-Brand Devices [4Klear]

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• 00817613020673: 4Klear Camera / Medical Recorder - Includes 9M Camera Cable
• 00817613020666: 4Klear Camera / Medical Recorder - Includes 3M Camera Cable
• 00817613020536: 4Klear Camera / Medical Recorder - Includes 6M Camera Cable
• 00817613020833: 4Klear Camera / Medical Recorder - Includes 6M Camera Cable
• 00817613020826: 4Klear Camera / Medical Recorder - Includes 3M Camera Cable
• 00817613020819: 4Klear Camera / Medical Recorder - Includes 9M Camera Cable
• 00817613020802: 4Klear Camera / Medical Recorder - Includes 15M Camera Cable