VITALOGRAPH (IRELAND) LIMITED

Address:Gort Road Business Park,Co Clare,IE

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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

SPIROMETER, DIAGNOSTIC (BZG) (9) PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) (BTA) (1)

Premarket Exempt

No Yes

Clear

Mouthpiece - 15099169209890 Catalog Number :

Device Description : Oval MOUTHPIECES

Device Class : 2

Duns Number: 219683489

Premarket Exempt : Yes

Product Code : BZG

Prescription Use : No

Device Count : 1

Aspirator - 15099169251004 Catalog Number :

Device Description : 2510 EMERGENCY ASPIRATOR(1)

Device Class : 2

Duns Number: 219683489

Premarket Exempt : No

Product Code : BTA

Prescription Use : No

Device Count : 1

BVF - 15099169283500 Catalog Number :

Device Description : 2820 BV FILTER

Device Class : 2

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

BVF - 15099169283623 Catalog Number :

Device Description : 2820 BV FILTER UNIVERSAL 30mm ID

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

BVF - 15099169283630 Catalog Number :

Device Description : 2820 BV FILTER TYPE J - BOX OF 50

Device Class : 2

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

BVF - 15099169283654 Catalog Number :

Device Description : 2820 BV FILTER TYPE MG

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

BVF - 15099169283678 Catalog Number :

Device Description : 2820 BV FILTER

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

BVF - 15099169283685 Catalog Number :

Device Description : 2820 BV FILTER TYPE K

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

PFT - 15099169283708 Catalog Number :

Device Description : 2820 BV FILTER + 2030 NOSE CLIPS (28350 + 20243)

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

PFT - 15099169283715 Catalog Number :

Device Description : 2820 BV FILTER + 2030 NOSE CLIPS (28363 + 20243)

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

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