Battery Power Subassembly

GUDID 00851446007081

The Model 300126 Battery Power Subassembly is Model 3001-C Battery Charger and QTY 2 Model 100026 Batteries as a subassembly, but is packaged separately from a system configuration.

VITA HEAT MEDICAL

Primary battery

• Primary Device ID: 00851446007081
• NIH Device Record Key: f037305b-0042-49e4-af4d-04317a08dc18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Battery Power Subassembly
• Version Model Number: 300126
• Company DUNS: 021249224
• Company Name: VITA HEAT MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.850.8350
• Email: pfarmakis@vitaheatmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851446007081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132454

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-23

Devices Manufactured by VITA HEAT MEDICAL

• 00851446007043 - Battery Charger: 2020-02-06 The Model 3001-C Battery Charger provides charging power to a Model 100026 Batteries.
• 00851446007081 - Battery Power Subassembly: 2020-02-06The Model 300126 Battery Power Subassembly is Model 3001-C Battery Charger and QTY 2 Model 100026 Batteries as a subassembly, but is packaged separately from a system configuration.
• 00851446007081 - Battery Power Subassembly: 2020-02-06 The Model 300126 Battery Power Subassembly is Model 3001-C Battery Charger and QTY 2 Model 100026 Batteries as a subassembly, bu
• 00851446007005 - Patient Warming Mattress: 2018-07-06 The Model 4003 Patient Warming Mattress is an electrical patient warming mattress that is connected to a Model 2002 Controller a
• 00851446007012 - Controller: 2018-07-06 The Model 2002 Controller regulates the temperature of and the power to the Model 4003 Patient Warming Mattress. It is powered
• 00851446007036 - Battery: 2018-07-06 The Model 100026 Battery provides power to the Model 2002 Controller. The Battery is charged by the 3001-C Battery Charger.
• 00851446007067 - AC Power Adapter: 2018-07-06 The Model 100026-PA AC Power Adapter Provides power to the Model 2002 Controller.
• 00851446007098 - AC Power Adapter Subassembly Kit: 2018-07-06 The Model 100026-PA-SA AC Power Adapter Subassembly is a Model 100026-PA AC Power Adapter as a subassembly. This includes Model
• 00851446007104 - VitaHEAT UB3 Patient Warming System - Battery Power: 2018-07-06 The Model 7003-A, VitaHEAT UB3 Patient Warming System - Battery Power includes a Model 4003 Patient Warming Mattress, a Model 20