Health o meter Professional

Basic Information

• Brand Name: Health o meter Professional
• Primary DI: 00850017694576
• Version / Model: 2210KG-AMCT
• Company Name: Pelstar, LLC
• Labeler DUNS: 037289290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-10
• Public Version: 1
• Public Version Date: 2022-01-18
• Public Version Status: New
• Public Device Record Key: 1ae13fc7-aabb-45a7-8844-0f26d58bc3eb

Device Description

Antimicrobial High Resolution Digital Neonatal/Pediatric Tray Scale with Cart; KG only

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
FRW	Scale, Patient	General Hospital	880.2720	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35324	Infant scale, electronic	An electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes, e.g., during critical care procedures. It typically consist of a weight tray, a flexure plate or bending beam, an electronic transducer, and an analogue or digital display; it may include markings to also measure infant length. The device is also known as paediatric or baby scale.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850017694576	GS1