HALO INNOVATIONS, INC.

Address:213 West 35th Street, Suite 2E,New York,NY,10001,US

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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

Bassinet, Hospital (NZG) (1) Bed, Pediatric Open Hospital (FMS) (1)

Premarket Exempt

Yes

Clear

Bassinest Hospital Series - 00818771000002 Catalog Number :

Device Description : The HALO Hospital Bassinest is designed to be a sleeping surface for infant/newb The HALO Hospital Bassinest is designed to be a sleeping surface for infant/newborn patients. The top surface of the device raises and lowers to allow easier access to the infant/newborn. The HALO Hospital Bassinest was also designed for in-hospital transport within newborn labor/delivery units, postpartum units, medical surgical units treating high risk pregnancy patients, NICU’s, and any other patient areas within a hospital where a newborn infant may be treated and/or cared for during hospital admissions. This product is NOT INTENDED for patients that can crawl or reposition themselves independently

Device Class : 2

Duns Number: 825255706

Premarket Exempt : Yes

Product Code : NZG

Prescription Use : No

Device Count : 1

Bassinest - 00818771039606 Catalog Number :

Device Class : 2

Duns Number: 825255706

Premarket Exempt : Yes

Product Code : FMS

Prescription Use : No

Device Count : 1

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