PeriFlux 6000

GUDID 07332834000066

PeriFlux 6000

Perimed AB

Laser Doppler blood flowmeter

• Primary Device ID: 07332834000066
• NIH Device Record Key: dcaf89b6-fbf7-41a7-807e-d5f58dc72b8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriFlux 6000
• Version Model Number: PF 6000
• Company DUNS: 354765570
• Company Name: Perimed AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332834000066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152930

FDA Product Code

• DPW: Flowmeter, Blood, Cardiovascular

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: 2021-10-28
• Device Publish Date: 2021-10-20

Devices Manufactured by Perimed AB

• 07332834000790 - PF 6840-1 TC Remote Panel 1 Channel: 2023-02-09 PF 6840-1 TC Remote Panel 1 Channel
• 07332834000806 - PF 6840-2 TC Remote Panel 2 Channels: 2023-02-09 PF 6840-2 TC Remote Panel 2 Channels
• 07332834000820 - PF 6840-4 TC Remote Panel 4 Channels: 2023-02-09 PF 6840-4 TC Remote Panel 4 Channels
• 07332834000066 - PeriFlux 6000: 2021-10-28PeriFlux 6000
• 07332834000066 - PeriFlux 6000: 2021-10-28 PeriFlux 6000
• 07332834000608 - PH 07-5 Small Tape-Fixated Probe Holder: 2021-06-02 PH 07-5 Small Tape-Fixated Probe Holder (5 pcs)
• 07332834000387 - MT B500-0L120 Straight Microtip: 2020-04-23 MT B500-0L120 Straight Microtip
• 07332834000394 - MT B500-0L240 Straight Microtip: 2020-04-23 MT B500-0L240 Straight Microtip
• 07332834000288 - TC 550 Fixation Ring for tcpO2/CO2 (50 pcs) and TC 560 Contact Liquid: 2019-12-13 Convenience kit including: TC 550 Fixation Ring for tcpO2/CO2 (50 pcs) TC 560 Contact Liquid (20 ml)