BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

N/A

DI: 00840682104579 · Model: 420915-056 · 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: N/A
Primary DI: 00840682104579
Version / Model: 420915-056
Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Labeler DUNS: 784985108
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-06-24
Public Version: 4
Public Version Date: 2025-08-12
Public Version Status: Update
Public Device Record Key: 3b82e513-04be-4fb9-83be-8619506c45ed
Distribution End Date: 2020-10-16

Device Description

ASSY DIDCA ASPECT BIS A-2000 AUTOPORT

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: Yes
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
MWI	MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682104579	GS1

Customer Contacts

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

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -40 – 70 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 15 – 95 Percent (%) Relative Humidity