Spacelabs Healthcare

Basic Information

• Brand Name: Spacelabs Healthcare
• Primary DI: 10841522106897
• Version / Model: EVENTREC
• Catalog Number: CCST80
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Labeler DUNS: 145581588
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-21
• Public Version: 4
• Public Version Date: 2019-01-31
• Public Version Status: Update
• Public Device Record Key: 5539f2be-de29-4ab5-98b3-512e05c2e6ac
• Distribution End Date: 2019-01-31

Device Description

CARDIOCALL ST80,ENGLISH ECG RECORDER

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
DXH	TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE	Cardiovascular	870.2920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36827	Electrocardiographic long-term ambulatory recording analyser	An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841522106897	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity