Medela AG

Address:LAETTICHSTRASSE 4B,BAAR Zug,CH

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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) (8) Negative Pressure Wound Therapy Powered Suction Pump (OMP) (2)

Premarket Exempt

No Yes

Clear

Accessories for Vario 18 pump - 07612367022910 Catalog Number :

Device Description : Accessories for Vario 18 pump consisting of disposable tubing (077.0952)

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Vario 18 AC - 07612367023221 Catalog Number :

Device Description : Powered suction pumpOverflow protection /bacteria filterSilicone tubingPSU jar 0 Powered suction pumpOverflow protection /bacteria filterSilicone tubingPSU jar 0.25lLid to PSU jarDisposable tubing

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Serial connection, patient - 07612367023290 Catalog Number :

Device Description : Tubing for collection system

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 100

Given Vario Pump Kit - 07612367024419 Catalog Number :

Device Description : Given Vario Pump Kit consisting of jar 0.25l, lid to jar, silicone tubing and di Given Vario Pump Kit consisting of jar 0.25l, lid to jar, silicone tubing and disposable tubing

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Docking Station - 07612367024426 Catalog Number :

Device Description : Docking Station for battery powered suction pump (e.g Invia Liberty or Thopaz)

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Thopaz tubing single, small connector - 07612367024754 Catalog Number :

Device Description : Single Tubing with small connector for thoracic suction system pump

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thopaz disposable canister 2l - 07612367024778 Catalog Number :

Device Description : Canister for thoracic suction System pump

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thopaz disposable canister with solidifier, 2l - 07612367024785 Catalog Number :

Device Description : Canister for thoracic suction System pump

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Invia Motion 60 Days - 07612367026260 Catalog Number :

Device Description : Negative Pressure Wound Therapy System / 087.4000

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Suction Bag 1.5l - 07612367031325 Catalog Number :

Device Description : Disposable Suction Bag 1.5l for disposable collection system

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 40

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