Spacelabs Healthcare

Basic Information

• Brand Name: Spacelabs Healthcare
• Primary DI: 10841522129117
• Version / Model: 91449
• Catalog Number: 91449
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Labeler DUNS: 145581588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-07
• Public Version: 1
• Public Version Date: 2021-05-17
• Public Version Status: New
• Public Device Record Key: 45e298c0-ce60-4d24-892b-a7419a3a9152

Device Description

DESKTOP 50MM PRINTER

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: 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
DSF	RECORDER, PAPER CHART	Cardiovascular	870.2810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36585	Patient monitoring system module, printing	A small unit dedicated to providing a print-out of patient related data, e.g., an electrocardiogram (ECG), blood pressure, haemoglobin oxygen saturation (SpO2). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer providing the information requested for the print-outs from this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841522129117	GS1