HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00849027002648
• Version / Model: HCS9100-5
• Company Name: DYAD MEDICAL SOURCING, LLC
• Labeler DUNS: 078572603
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-01-13
• Public Version: 4
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 73972937-8ad6-498c-b992-f52d230e5cae

Device Description

Electrode

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: 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
DRX	Electrode, Electrocardiograph	Cardiovascular	870.2360	2

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	10849027002645	GS1	Case	2000	In Commercial Distribution
Primary	00849027002648	GS1
Package	30849027002649	GS1	Inner Box	500	In Commercial Distribution
Unit of Use	84902700264800	GS1

Premarket Submissions

Submission Number	Supplement Number
K041954	000