FDA.reportPublic FDA data

softFlow

Primary DI
04059163000620
Brand
softFlow
Company
TNI medical AG
Model
40620600
Catalog number
40620600
Device description
Accessories Set Clinic USA softFlow 50
Published
2021-03-15
Public version status
New
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
04059163000620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059163000620040591630006204059163000620

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory line humidification chamber, single-useA 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.

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059163000408softFlow40620061406200612021-03-15
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

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Primary DI, Brand, Company table
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10197344009749HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-10-31
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