softFlow

Basic Information

• Brand Name: softFlow
• Primary DI: 04059163000071
• Version / Model: 40630013
• Catalog Number: 40630013
• Company Name: TNI medical AG
• Labeler DUNS: 312602830
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-15
• Public Version: 1
• Public Version Date: 2021-03-23
• Public Version Status: New
• Public Device Record Key: f7c71be4-518a-4325-8623-37ce3d5677da

Device Description

Applicator Clinic Large softFlow 50

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60699	Inspiratory line humidification chamber, single-use	A device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a plastic chamber intended to allow the water to be heated by the attached humidifier and the subsequent vapour to be delivered to the patient through a connected breathing circuit. It may be used in a healthcare setting or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04059163000071	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -29 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -29 – 70 Degrees Celsius