IC PROFILER 1122000-0Z

GUDID 05060608880751

Radiation therapy QA device.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: 05060608880751
• NIH Device Record Key: 8889735c-0182-47ab-b391-412b01b2c6a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IC PROFILER
• Version Model Number: 1122800Z
• Catalog Number: 1122000-0Z
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: true
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880751 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

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: 2020-07-31
• Device Publish Date: 2020-07-23

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