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

Bottle, Collection, Vacuum (KDQ) (2) Extractor, Vacuum, Fetal (HDB) (1) Pump, Breast, Powered (HGX) (1) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (1) System, Suction, Lipoplasty (MUU) (1) System, Suction, Lipoplasty For Removal (QPB) (1)

Premarket Exempt

No Yes

Clear

Freestyle Flex - 07612367071918 Catalog Number :

Device Description : Breast Pump

Device Class :

Duns Number: 488293218

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Thopaz Tubing Extension, 1 Line, sterile - 07612367078115 Catalog Number :

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

Thopaz Tubing Extension, 3 Lines, sterile - 07612367078139 Catalog Number :

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

J&J DePuy Synthes convenience kit - 07612367080590 Catalog Number : 101043438

Device Description : Convenience kit containing:1 x Dominant Flex Rack (item # 071.0003 ) with U.S. Convenience kit containing:1 x Dominant Flex Rack (item # 071.0003 ) with U.S. power cord1 pack of Coupling Piece 90° (item # 077.1019, 10 pieces)1 x IFU of each language region (EU 1, EU 2, Japan, Korea, China)

Device Class : 2

Duns Number: 488293218

Premarket Exempt : No

Product Code : BTA, HDB, MUU, QPB

Prescription Use : Yes

Device Count : 1

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