softFlow 40630002

GUDID 04059163000057

Applicator Clinic Standard softFlow 50

TNI medical AG

Inspiratory line humidification chamber, single-use

• Primary Device ID: 04059163000057
• NIH Device Record Key: 6c7fb078-0e95-4331-85a6-ca6b16961553
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: softFlow
• Version Model Number: 40630002
• Catalog Number: 40630002
• Company DUNS: 312602830
• Company Name: TNI medical AG
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de
• Phone: +4993120792902
• Email: info@tni-medical.de

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059163000057 [Primary]

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

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: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [softFlow]

• 04059163000774: TNI softFlow 50
• 04059163000620: Accessories Set Clinic USA softFlow 50
• 04059163000545: Humidifier Clinic Hygiene Set softFlow
• 04059163000415: TNI softFlow 50
• 04059163000408: Protective Cap f. Oxygen Inlet White, softFlow, 5 Pieces
• 04059163000231: Air Bridge Humidifier softFlow
• 04059163000224: Humidifier Rack Clinic softFlow
• 04059163000071: Applicator Clinic Large softFlow 50
• 04059163000064: Applicator Clinic Std.-Plus softFlow 50
• 04059163000057: Applicator Clinic Standard softFlow 50
• 04059163000040: Applicator Clinic Small softFlow 50