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) (7) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (3) System, Suction, Lipoplasty For Removal (QPB) (1)

Premarket Exempt

No Yes

Clear

Invia Foam Dressing Kit - 07612367050067 Catalog Number :

Device Description : Invia Foam Dressing Kit with Fitpad - MediumSales number: 087.6222 3 PCs / 087.6226 15 pcs

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Foam Dressing Kit - 07612367050098 Catalog Number :

Device Description : Invia Foam Dressing Kit with Fitpad - LargeSales number: 087.6223 3 PCs / 087.6227 15 pcs

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Foam Dressing Kit - 07612367050128 Catalog Number :

Device Description : Invia Foam Dressing Kit with Fitpad - X-LargeSales number: 087.6224 3 PCs

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Gauze Dressing Kit - 07612367050142 Catalog Number :

Device Description : Invia Gauze Dressing Kit with Fitpad - Medium087.7170 3 pcs / 087.7172 15 pcs

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Gauze Dressing Kit - 07612367050173 Catalog Number :

Device Description : Invia Gauze Dressing Kit with FitPad - Large - 087.7171 3pcs

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Invia Transparent Film - 07612367050227 Catalog Number :

Device Description : Invia Transparent Film - 087.0030 - 10 pcs

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Tubing 2M Single - 07612367051132 Catalog Number :

Device Description : Tubing 2 M Single. Model No. MAJ-103 K. 3920733

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA, QPB

Prescription Use : Yes

Device Count : 1

Invia Motion Canister /Tubing Set - 07612367051248 Catalog Number :

Device Description : Invia Motion Canister /Tubing Set 150ml - 087.4016

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Wall bracket, single - 07612367051484 Catalog Number :

Device Description : Holder for accessories can be attached to the wall

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Vario 18 AC - 07612367052443 Catalog Number :

Device Description : Powered suction pumpOverflow protection filterSilicone tubingPSU jar 0.25lLid to Powered suction pumpOverflow protection 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

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