SPACELABS HEALTHCARE

Basic Information

• Brand Name: SPACELABS HEALTHCARE
• Primary DI: 30841522122860
• Version / Model: TAY
• Catalog Number: 50-0191
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Labeler DUNS: 145581588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2d8a6aa1-f609-4856-9ebc-2468ddb549f5

Device Description

HOOK UP KIT WITH SINGLE USE POUCH, CASE OF 20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
DSH	RECORDER, MAGNETIC TAPE, MEDICAL	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62149	Electrocardiographic long-term ambulatory recording support kit	A collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30841522122860	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius