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) Extractor, Vacuum, Fetal (HDB) (1) System, Suction, Lipoplasty (MUU) (1) System, Suction, Lipoplasty For Removal (QPB) (1)

Premarket Exempt

No Yes

Clear

Suction jar polysulfone 2l - 07612367002707 Catalog Number :

Device Description : Suction jar for reusable collection system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Suction jar polysulfone 3l - 07612367002714 Catalog Number :

Device Description : Suction jar for reusable collection system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Suction jar polysulfone 5l - 07612367002721 Catalog Number :

Device Description : Suction jar for reusable collection system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Large lid with conical patient connection 6–10 mm - 07612367002806 Catalog Number :

Device Description : Large lid with conical patient connection 6–10 mm for reusable collection system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Large lid with conical patient connection 10–14 mm - 07612367002813 Catalog Number :

Device Description : Large lid with conical patient connection 10–14 mmand overflow protection device

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Small lid with conical patient connection and overflow protection device - 07612367002820 Catalog Number :

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Lid for safety Set with overflow protection device - 07612367002837 Catalog Number :

Device Description : Lid for safety Set with overflow protection device for professional vacuum system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Disposable Specimen Cup - 07612367003582 Catalog Number :

Device Description : Disposable Specimen Cup for suction system (Ø 6-10 mm)

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 10

Change-over valve with clampholder and tubing set - 07612367003599 Catalog Number :

Device Description : Change-over valve with clampholder and tubing set for professional vacuum system

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Clip for Lid - 07612367003681 Catalog Number :

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA, HDB, MUU, QPB

Prescription Use : Yes

Device Count : 10

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