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) (8) Pump, Breast, Powered (HGX) (1) Tubing, Noninvasive (GAZ) (1)

Premarket Exempt

No Yes

Clear

Disposable Overflow Protection / Virus Filter - 07612367064682 Catalog Number :

Device Description : Disposable Overflow Protection / Virus Filter, conical connection

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable Overflow Protection / Bacteria Odour Filter - 07612367064712 Catalog Number :

Device Description : Disposable Overflow Protection / Bacteria Odour Filter with conical connection

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable Overlfow Protection / Virus Odour Filter - 07612367064743 Catalog Number :

Device Description : Disposable Overlfow Protection / Virus Odour Filter with Medela connections

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable Overflow Protection / Virus Odour Filter - 07612367064774 Catalog Number :

Device Description : Disposable Overflow Protection / Virus Odour Filter with conical Connections

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable virus filter - 07612367064804 Catalog Number :

Device Description : Disposable virus filter with Medela connections

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable virus filter - 07612367064835 Catalog Number :

Device Description : Disposable virus filter with conical connections

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable virus / odour filter - 07612367064866 Catalog Number :

Device Description : Disposable virus / odour filter with Medela Connection

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Diposable virus / odour Filter - 07612367064897 Catalog Number :

Device Description : Diposable virus / odour Filter with conical Connections

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : No

Device Count : 10

Freestyle Flex Tubing - 07612367071376 Catalog Number :

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : GAZ

Prescription Use : No

Device Count : 1

PersonalFit Flex Connector - 07612367071406 Catalog Number :

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

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