MR Patient Care Thermal Printer Kit, USB

Basic Information

• Brand Name: MR Patient Care Thermal Printer Kit, USB
• Primary DI: 00884838106468
• Version / Model: Printer Kit, Strip Chart, USB
• Catalog Number: 989803181881
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-21
• Public Version: 4
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 306957aa-9a7b-400c-be0a-5092ed0c90cc
• Distribution End Date: 2022-12-15

Device Description

Non-MRI, USB strip-chart printer for the Expression Information Portal. Includes printer with USB cable and power adapter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
DSF	Recorder, Paper Chart	Cardiovascular	870.2810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34937	Paper chart recorder	A mains electricity (AC-powered) electronic device, which may include internal rechargeable batteries, intended to receive an input signal (e.g., from a physiological amplifier, signal conditioner, computer) which it converts and transcribes onto paper so that the information is stored in the form of a permanent document (hard copy). It will typically include a paper chart driven at constant speed by a motor and a pen(s) that moves back and forth in response to the signal, a printing array (e.g., thermal or electrostatic), or another device for printing on paper. It may be stationary or portable and will typically be used in the absence of a built-in chart recorder.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838106468	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 570 – 1020 millibar
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 429 – 765 Millimeter of Mercury
• Type: Storage Environment Humidity
• Temperature Range: 5 – 80 Percent (%) Relative Humidity