ESU LIMITED LIABILITY PARTNERSHIP

Address:3-23-28 Shimoasao, Asao-Ku,Kawasaki Kanagawa,JP

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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

Transilluminator, Battery-Powered (HJN) (1)

Premarket Exempt

Yes

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ESU TRANSILLUMINATOR - 00860003720509 Catalog Number :

Device Description : The device supports the identification of veins in neonates and infants for veni The device supports the identification of veins in neonates and infants for venipuncture through the use of an LED that emits a wavelength close to the "optical window," allowing for deeper light penetration into human tissue.

Device Class : 1

Duns Number: 716244660

Premarket Exempt : Yes

Product Code : HJN

Prescription Use : No

Device Count : 1

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