ADVANCED INFANT WARMER

Basic Information

• Brand Name: ADVANCED INFANT WARMER
• Primary DI: B510A4051
• Version / Model: A4051
• Company Name: ADVANCED INSTRUMENTATIONS, INC.
• Labeler DUNS: 608736880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-07
• Public Version: 1
• Public Version Date: 2025-02-17
• Public Version Status: New
• Public Device Record Key: 7b77a823-a09d-4d63-a478-a2d104214b74

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: No
• 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
FMZ	Incubator, Neonatal	General Hospital	880.5400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17433	Infant warmer	A mains electricity (AC-powered) mobile device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B510A4051	HIBCC