Charger

Basic Information

• Brand Name: Charger
• Primary DI: 00847946019976
• Version / Model: 1119-0500-66
• Company Name: Zoll Medical Corporation
• Labeler DUNS: 055363428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-06
• Public Version: 4
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: f2d0a2b1-1295-4c4d-81da-964356c48ada

Device Description

SUREPOWER CHARGING STATION, REFURB

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
NSX	Software, transmission and storage, patient data
LDD	Dc-defibrillator, low-energy, (including paddles)	Cardiovascular	870.5300	2
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	Cardiovascular	870.1130	2
MKJ	Automated external defibrillators (non-wearable)	Cardiovascular	870.5310	3
DSK	COMPUTER, BLOOD-PRESSURE	Cardiovascular	870.1110	2
LIX	Aid, cardiopulmonary resuscitation	Cardiovascular	870.5210	2
DRO	PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)	Cardiovascular	870.5550	2
DQA	Oximeter	Cardiovascular	870.2700	2
DRT	MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847946019976	GS1

Premarket Submissions

Submission Number	Supplement Number
K142915	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: Low: 0 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 0 – 0 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 0 – 0 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 0 Percent (%) Relative Humidity