BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

CARESCAPE

DI: 00840682109260 · Model: Telemetry Server V4 · 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: CARESCAPE
Primary DI: 00840682109260
Version / Model: Telemetry Server V4
Company Name: GE Medical Systems Information Technologies, Inc.
Labeler DUNS: 006580799
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-06-10
Public Version: 7
Public Version Date: 2026-02-25
Public Version Status: Update
Public Device Record Key: d0cbe8d8-2a84-4ebe-8c2b-08be1b1bc1b3
Distribution End Date: 2023-01-27

Device Description

TELEMETRY SERVER V4 ATO MODEL

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
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682109260	GS1

Customer Contacts

Phone: +1(800)558-5120
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080251	000

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -40 – 70 Degrees Celsius