BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

SEER

DI: 00840682108201 · Model: 12 · Ge Medical Systems Information Technologies, 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: SEER
Primary DI: 00840682108201
Version / Model: 12
Company Name: Ge Medical Systems Information Technologies, Inc.
Labeler DUNS: 118935631
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-06-15
Public Version: 6
Public Version Date: 2025-05-09
Public Version Status: Update
Public Device Record Key: a5b0a3eb-7b96-4f46-b169-49df3ba9a291

Device Description

SEER 12

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: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
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
MWJ	ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35162	Electrocardiographic ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682108201	GS1

Customer Contacts

Phone: +1(800)558-7044
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K063042	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -20 – 65 Degrees Celsius