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) System, Suction, Lipoplasty For Removal (QPB) (1)

Premarket Exempt

No Yes

Clear

Silicone tubing - 07612367004251 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 - 07612367004268 Catalog Number :

Device Description : Silicone tubing with one coupling piece

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Silicone tubing - 07612367004282 Catalog Number :

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Silicone Tubing - 07612367004299 Catalog Number :

Device Description : Silicon tubing with two coupling pieces

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Silicone tubing - 07612367004305 Catalog Number :

Device Description : Silicone tubing with one coupling piece and angle piece

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Disposable tubing - 07612367004312 Catalog Number :

Device Description : Disposable tube PVC, 180cm, CH25, fingertip

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA, QPB

Prescription Use : Yes

Device Count : 1

Plug for FMS lids - 07612367005098 Catalog Number :

Device Description : Plug for fluid Management System lids

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Angle piece - 07612367005104 Catalog Number :

Device Description : Angle Piece Diameter 6-10mm

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Angle piece - 07612367005111 Catalog Number :

Device Description : Angle Piece diamter 10-14mm

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Disposable Specimen Cup - 07612367005135 Catalog Number :

Device Description : Disposable specimen Cup for suction system (Ø 10 - 14 mm)

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

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