LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI

Address:Zafer SB MAh Gunduz Sk No:13 Ege Serbest Bolge Gaziemir IZmir,Izmir,TR

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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, Breast, Powered (HGX) (6) Pump, Breast, Non-Powered (HGY) (1)

Premarket Exempt

No Yes

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Lansinoh Manual Breast Pump - 20044677505202 Catalog Number : 50520

Device Description : The Non-Powered Breast Pump is intended to express and collect the breast milk o The Non-Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby.

Device Class :

Duns Number: 502960539

Premarket Exempt : Yes

Product Code : HGY

Prescription Use : No

Device Count : 2

Lansinoh 5oz Bottle with NaturalWave Nipple– Triple Pack - 20044677710545 Catalog Number :

Device Description : İt is used for baby feeding.

Device Class :

Duns Number: 502960539

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 3

Lansinoh 8oz Bottle with NaturalWave Nipple – Triple Pack - 20044677710569 Catalog Number :

Device Description : It is used for baby feeding.

Device Class :

Duns Number: 502960539

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 3

Lansinoh Breastmilk Storage Bottle-4 Pack - 30044677204157 Catalog Number :

Device Description : It is used for mother milk collection and storage after and during milking from It is used for mother milk collection and storage after and during milking from mother breast.

Device Class :

Duns Number: 502960539

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 4

NaturalWave Fast Flow Teats-2pcs L size - 30044677710252 Catalog Number :

Device Description : It is used with milk bottle to provide milk flow during baby feeding.

Device Class :

Duns Number: 502960539

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 2

NaturalWave Medium Flow Teats-2pcs M size - 30044677710269 Catalog Number :

Device Description : It is used with milk bottle to provide milk flow during baby feeding.

Device Class :

Duns Number: 502960539

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 2

NaturalWave Slow Flow Teats - 2pcs S size - 30044677710276 Catalog Number :

Device Description : It is used with milk bottle to provide milk flow during baby feeding.

Device Class :

Duns Number: 502960539

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 2

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