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)

Premarket Exempt

No Yes

Clear

Foot vacuum regulator - 07612367003933 Catalog Number :

Device Description : Foot vacuum Regulator for adjustment of vacuum by foot for Dominant Flex and Basic

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Disposable overflow protection / bacteria filter - 07612367003957 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

Safety device plugged into pump - 07612367004138 Catalog Number :

Device Description : Safety set for Basic and Dominat Flex as well as Basic 30 and Dominant 50

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Disposable overflow protection / bacteria filter - 07612367004152 Catalog Number :

Device Description : Disposable overflow protection / bacteria filter with conical connection

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable bacteria filter - 07612367004169 Catalog Number :

Device Description : Disposable bacteria filter with Medela connection

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable bacteria filter - 07612367004176 Catalog Number :

Device Description : Disposable bacteria filter with conical connection

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable bacteria / odour filter - 07612367004183 Catalog Number :

Device Description : Disposable bacteria / odour filter with Medela connection

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable bacteria /odour filter - 07612367004190 Catalog Number :

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Silicone tubing - 07612367004237 Catalog Number :

Device Description : Silicone tubing without coupling pieces

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Silicone tubing - 07612367004244 Catalog Number :

Device Description : Silicone tubing for suction system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

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