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

Negative Pressure Wound Therapy Powered Suction Pump (OMP) (6) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (4) Mesh, Surgical, Polymeric (FTL) (1)

Premarket Exempt

No Yes

Clear

AXS Universal Aspiration Tubing - 07612367052719 Catalog Number :

Device Description : The Tubing is used to transport body fluid from the suction catheter into a coll The Tubing is used to transport body fluid from the suction catheter into a collection canister or to transfer vacuum from the pump to the treatment site.

Device Class :

Duns Number: 488293218

Premarket Exempt : Yes

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Invia Motion Endure - 07612367052849 Catalog Number :

Device Description : Negative Pressure Wound Therapy System / 087.4010

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Motion 15 Days - 07612367053167 Catalog Number :

Device Description : Negative Pressure Wound Therapy System / 087.4012

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Motion 60 Days - 07612367053174 Catalog Number :

Device Description : Negative Pressure Wound Therapy System / 087.4014

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Abdominal Dressing Kit - 07612367054003 Catalog Number :

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : FTL, OMP

Prescription Use : Yes

Device Count : 1

AXS Universal Liner Set - 07612367054959 Catalog Number :

Device Description : The Medela Disposable Collection System is suitable for the safe collection and The Medela Disposable Collection System is suitable for the safe collection and disposal of suctioned fluids.

Device Class :

Duns Number: 488293218

Premarket Exempt : Yes

Product Code : BTA

Prescription Use : Yes

Device Count : 3

Invia White Foam NPWT - 07612367057493 Catalog Number :

Device Description : PVA foam dressing - small

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia White Foam NPWT - 07612367057509 Catalog Number :

Device Description : PVA foam dressing - large

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

AXS Universal Liner Set with Solidifier - 07612367060608 Catalog Number :

Device Description : Contains a disposable collection system liner with a specimen cup.

Device Class :

Duns Number: 488293218

Premarket Exempt : Yes

Product Code : BTA

Prescription Use : Yes

Device Count : 3

Diposable Overflow Protection / Virus filter - 07612367064651 Catalog Number :

Device Description : Diposable Overflow Protection / Virus filter with Medela connection

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

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