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) (9) Negative Pressure Wound Therapy Powered Suction Pump (OMP) (1)

Premarket Exempt

No Yes

Clear

Vario 18 AC - 07612367016094 Catalog Number : 600.2607

Device Description : Powered suction pump026.2120

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Holder with standard rail - 07612367016339 Catalog Number :

Device Description : Holder with standard rail for attachment of powered suction pump (e.g Invia Libe Holder with standard rail for attachment of 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

Foot ON/OFF switch for Basic/Dominant - 07612367017435 Catalog Number :

Device Description : Foot ON/OFF switch for Basic/Dominant

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thopaz - 07612367017480 Catalog Number : 200.2219

Device Description : Thoracic suction system pump 079.0002

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thopaz - 07612367017497 Catalog Number : 200.2219

Device Description : Thoracic suction system pump 079.0003

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Vario 18 AC - 07612367019118 Catalog Number : 600.2607

Device Description : Powered suction pumpwithOverflow protection / bacteria filterSilicone tubingPSU Powered suction pumpwithOverflow 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

Thopaz disposable canister with solidifier, 0.8l - 07612367020299 Catalog Number :

Device Description : Canister for thoracic suction system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thopaz Sealing Cap - 07612367020534 Catalog Number :

Device Description : Sealing cap for closing of Thopaz tubing

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Serial connection, patient - 07612367022798 Catalog Number :

Device Description : Serial Connection for collection system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Accessories for Vario 18 pump - 07612367022903 Catalog Number :

Device Description : Accessories for Vario 18 pump consisting of overflow protection / bacteria filter 077.0571

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

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