Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 00304040016893
• Version / Model: 1127162
• Catalog Number: 1127162
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-12
• Public Version: 5
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 45a1e2ce-0621-439d-a5c2-cbcf4a8b69a7
• Distribution End Date: 2019-03-06

Device Description

PAD DEFIB CARDIAC SCIENCE

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKJ	Automated external defibrillators (non-wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
11130	Electrode conductive skin pad, single-use	A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10304040016890	GS1		10	Not in Commercial Distribution	2019-03-06
Primary	00304040016893	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius