FDA.reportPublic FDA data

softFlow

Primary DI
04059163000408
Brand
softFlow
Company
TNI medical AG
Model
40620061
Catalog number
40620061
Device description
Protective Cap f. Oxygen Inlet White, softFlow, 5 Pieces
Published
2021-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059163000408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059163000408040591630004084059163000408

GMDN Terms#

Term, Definition table
TermDefinition
High-flow heated respiratory humidifierA mains electricity (AC-powered) device designed to deliver high-flow (typically greater than 15 L/min) heated and humidified ambient air or air/oxygen to a patient as therapy for a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), bronchiectasis, xerostomia, and mucositis]. The gases are delivered to the patient's airway via the nose/mouth or a tracheostoma. It typically consists of a gas flow generator, a heating element, humidification chamber, and breathing tube(s). Healthcare providers prescribe the therapy, configure the breathing system, and adjust the patient settings; the device may be used in the hospital or home for spontaneously breathing patients.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-29 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4993120792902info@tni-medical.de

Regulatory Flags#

DUNS number
312602830
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059163000415softFlow40610021406100212021-03-15
04059163000774softFlow40610200406102002021-03-15
04059163000040softFlow40630001406300012021-03-15
04059163000057softFlow40630002406300022021-03-15
04059163000064softFlow40630005406300052021-03-15
04059163000071softFlow40630013406300132021-03-15
04059163000224softFlow40641107406411072021-03-15
04059163000231softFlow40641108406411082021-03-15
04059163000545softFlow40620040406200402021-03-15
04059163000620softFlow40620600406206002021-03-15

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Primary DI, Brand, Company table
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