Bassinest Hospital Series

GUDID 00818771039606

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

HALO INNOVATIONS, INC.

Newborn-infant bed Newborn-infant bed Newborn-infant bed Neonatal bed Neonatal bed Neonatal bed Neonatal bed Neonatal bed

• Primary Device ID: 00818771039606
• NIH Device Record Key: b50fe46a-b586-44e6-93de-de62e3bc8cb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bassinest Hospital Series
• Version Model Number: 3957
• Company DUNS: 825255706
• Company Name: HALO INNOVATIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818771000002 [Primary]
GS1	00818771039606 [Primary]

FDA Product Code

• FMS: Bed, Pediatric Open Hospital
• NZG: Bassinet, Hospital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-03
• Device Publish Date: 2019-03-26