Fogless International AB

Address:Storgatan 24,Vaggeryd Jonkoping,SE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tube Tracheostomy And Tube Cuff (JOH) (7) Condenser, Heat And Moisture (Artificial Nose) (BYD) (2) Forceps, General & Plastic Surgery (GEN) (1)

Premarket Exempt

No Yes

Clear

SPIRO - 07350061231008 Catalog Number : 702-2K; 702-5K

Device Description : SPIRO 702 Humidifier

Device Class :

Duns Number: 356432815

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

SPIRO - 07350061231046 Catalog Number : 703-10

Device Description : Shower Protector for SPIRO 702 Humidifier

Device Class :

Duns Number: 356432815

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 2

SPIRO - 07350061231060 Catalog Number : 705-10

Device Description : SPIRO Tweezers

Device Class :

Duns Number: 356432815

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 2

SPIRO - 07350061231084 Catalog Number : 707-10

Device Description : SPIRO Adapter (transparent) 13mm for SPIRO 702, 710, 710R and 711 to connect to SPIRO Adapter (transparent) 13mm for SPIRO 702, 710, 710R and 711 to connect to a non ISO 15 tapered connector

Device Class :

Duns Number: 356432815

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 2

SPIRO - 07350061231107 Catalog Number : 708-10

Device Description : SPIRO Adapter (white) 14mm for SPIRO 702, 710, 710R and 711 to connect to a non SPIRO Adapter (white) 14mm for SPIRO 702, 710, 710R and 711 to connect to a non ISO 15 tapered connector

Device Class :

Duns Number: 356432815

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 2

SPIRO - 07350061231121 Catalog Number : 710-1K; 710-2K; 710-5K

Device Description : SPIRO Speaking Valve With Oxygen Nipple

Device Class :

Duns Number: 356432815

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

SPIRO - 07350061231152 Catalog Number : 710R-2K; 710R-5K

Device Description : SPIRO Speaking Valve With Oxygen Nipple (Red)

Device Class :

Duns Number: 356432815

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

SPIRO - 07350061231183 Catalog Number : 711-1K; 711-2K; 711-5K

Device Description : SPIRO Speaking Valve Without Oxygen Nipple

Device Class :

Duns Number: 356432815

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

SPIRO - 07350061231220 Catalog Number : 730-10

Device Description : Shower Protection for SPIRO Speaking Valve models 710,710R,711

Device Class :

Duns Number: 356432815

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 2

SPIRO - 07350061231268 Catalog Number : 760

Device Description : SPIRO Basic Set Speaking Valve

Device Class : 2

Duns Number: 356432815

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

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