FDA.reportPublic FDA data

SPIRO

Primary DI
07350061231008
Brand
SPIRO
Company
Fogless International AB
Model
702
Catalog number
702-2K; 702-5K;
Device description
SPIRO 702 Humidifier
Published
2018-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYDCondenser, Heat And Moisture (Artificial Nose)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350061231022PackageGS12In Commercial Distribution
07350061231039PackageGS15In Commercial Distribution
07350061231008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350061231022073500612310227350061231022
07350061231039073500612310397350061231039
07350061231008073500612310087350061231008

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, reusableA canister-like device that, when used together with a dedicated humidifying insertable filter, connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube] to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dark and dry environment at normal indoor room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4636144100mail@fogless.se

Regulatory Flags#

DUNS number
356432815
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350061231220SPIRO730730-2K2018-03-31
07350061230353SPIROXXX2023-09-21
07350061231046SPIRO703703-2K2018-03-31
07350061231121SPIRO710710-1K; 710-2K; 710-5K2018-03-31
07350061231152SPIRO710R710R-1K; 710R-2K; 710R-5K2018-03-31
07350061231183SPIRO711711-1K; 711-2K; 711-5K;2018-03-31
07350061231268SPIRO760760-1K; 760-1KF2018-03-31
07350061231350SPIRO 740740-25K; 740-100K2018-03-31
07350061231060SPIRO705705-102018-03-31
07350061231084SPIRO707707-102018-03-31
07350061231107SPIRO708708-102018-03-31
07350061231091SPIRO707707-102018-03-31
07350061231114SPIRO708708-102018-03-31
07350061231237SPIRO730730-102018-03-31
07350061231077SPIRO705705-102018-03-31
07350061231282SPIRO7707702018-03-31

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Primary DI, Brand, Company table
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