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) (10) Extractor, Vacuum, Fetal (HDB) (1) System, Suction, Lipoplasty (MUU) (1) System, Suction, Lipoplasty For Removal (QPB) (1)

Premarket Exempt

No Yes

Clear

Silicone tubing - 07612367010535 Catalog Number :

Device Description : Silicone tubing (lenght 25m)

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Disposable Overflow Protection / Bacteria filter - 07612367011341 Catalog Number :

Device Description : Disposable Overflow Protection / Bacteria filter with Medela connection

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Filter paper for autoclavable bacteria filter - 07612367011365 Catalog Number :

Device Description : Filter paper for autoclavable bacteria filter

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA, HDB, MUU, QPB

Prescription Use : Yes

Device Count : 50

Thopaz disposable canister 0.3l - 07612367013758 Catalog Number :

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thopaz disposable canister 0.8l - 07612367013765 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

Suction jar 1.5l - 07612367013772 Catalog Number :

Device Description : Suction jar, 1.5l for disposable collection system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Suction jar 2.5l, polycarbonate, for disposable collection system - 07612367013802 Catalog Number :

Device Description : Suction jar 2.5l, polycarbonate, for disposable collection system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thopaz tubing single - 07612367014120 Catalog Number :

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

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thopaz - 07612367014205 Catalog Number : 200.2219

Device Description : Thoracic Vacuum Pump079.0000

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thopaz disposable canister with 0.3l - 07612367014212 Catalog Number :

Device Description : Canister for thoracic suction systempump

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

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