Medela AG

Address:LAETTICHSTRASSE 4B,BAAR Zug,CH

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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

Pump, Portable, Aspiration (Manual Or Powered) (BTA) (7) Negative Pressure Wound Therapy Powered Suction Pump (OMP) (3)

Premarket Exempt

No Yes

Clear

Thopaz tubing double - 07612367014229 Catalog Number :

Device Description : Double Tubing with large connector for thoracic suction system pump

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Disposable overflow protection /bacteria/odour filter - 07612367014250 Catalog Number :

Device Description : Disposable overflow protection /bacteria/odour filter for proffesional vacuum system

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Specimen Cup - 07612367015271 Catalog Number :

Device Description : Specimen Cup for reusable collection system

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Serial connection vacuum - 07612367015288 Catalog Number :

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Y-piece 7/5 mm Disposable System - 07612367015301 Catalog Number :

Device Description : Y-Piece for disposable system

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Y-piece 7 mm Disposable System - 07612367015318 Catalog Number :

Device Description : Connector for disposable system

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Adapter Vario - 07612367015387 Catalog Number :

Device Description : Adapter Vario for Attachement of disposable collection system

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 5

Invia Liberty canister 0.3l - 07612367015455 Catalog Number :

Device Description : Canister for negative pressure wound therapy powered suction pump

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Liberty canister 0.8l - 07612367015462 Catalog Number :

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Liberty - 07612367015578 Catalog Number : 200.2222

Device Description : Negative Pressure Wound Therapy Powered Suction Pump087.0000

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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