Arjohuntleigh AB

Address:HANS MICHELSENSGATAN 10,MALMO Skane,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

Mattress, Air Flotation, Alternating Pressure (FNM) (6) Device, Transfer, Patient, Manual (FMR) (4)

Premarket Exempt

No Yes

Clear

AIRPAL - 05059441185956 Catalog Number :

Device Description : AirPal SPS Disposable Transfer Pad, 28 in X 47 in, 10/CA

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

AIRPAL - 05059441185963 Catalog Number :

Device Description : AirPal SPS Disposable Transfer Pad, 34 in X 42 in 10/CA

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

AIRPAL - 05059441185970 Catalog Number :

Device Description : AirPal SPS Disposable Transfer Pad, 39 in X 78 in, 10/CA

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

AIRPAL - 05059441185987 Catalog Number :

Device Description : AirPal SPS Disposable Transfer Pad, 34 in X 78in 10/CA

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Auralis - 05059441200635 Catalog Number :

Device Description : AURALIS PUMP

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Auralis - 05059441200758 Catalog Number :

Device Description : AURALIS 200 MATTRESS NARROW

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Auralis - 05059441200772 Catalog Number :

Device Description : AURALIS 110 MATTRESS NARROW

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Auralis - 05059441200789 Catalog Number :

Device Description : AURALIS 200 MATTRESS STANDARD

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Auralis - 05059441200802 Catalog Number :

Device Description : AURALIS 110 MATTRESS STANDARD

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Auralis - 05059441200956 Catalog Number :

Device Description : AURALIS PLUS MATTRESS ASSEMBLY

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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