BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

3-Ch ECG Holter Patient Cable w/7 Leads

DI: 00817980020573 · Model: Model 1303 · VASOMEDICAL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: 3-Ch ECG Holter Patient Cable w/7 Leads
Primary DI: 00817980020573
Version / Model: Model 1303
Catalog Number: A10-0053
Company Name: VASOMEDICAL, INC.
Labeler DUNS: 197210248
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-11-29
Public Version: 4
Public Version Date: 2024-06-06
Public Version Status: Update
Public Device Record Key: 6bf82e6f-353f-4c1d-b053-e33d59f47841

Device Description

3-Ch ECG Holter Patient Cable w/7 Leads

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: 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
DSH	RECORDER, MAGNETIC TAPE, MEDICAL	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817980020573	GS1

Customer Contacts

Phone: +1(516)508-5818
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K111180	000