Bassinest

Basic Information

• Brand Name: Bassinest
• Primary DI: 00818771039606
• Version / Model: 3957
• Company Name: HALO INNOVATIONS, INC.
• Labeler DUNS: 825255706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-20
• Public Version: 2
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 5156c79d-06cf-4e9f-aa98-24b7e06bca2f

Device Description

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 Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMS	Bed, Pediatric Open Hospital	General Hospital	880.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38140	Neonatal bed	A bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on a wheeled framework (trolley). It is padded or lined with appropriate bedding and used mostly as the general-purpose or standard baby bed in birthing departments. A source of additional heating may be provided to the newborn.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818771039606	GS1