BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

N/A

DI: 00840682120104 · Model: M1051023 · GE Healthcare Finland Oy

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

Basic Information

Brand Name: N/A
Primary DI: 00840682120104
Version / Model: M1051023
Company Name: GE Healthcare Finland Oy
Labeler DUNS: 401966697
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-04-11
Public Version: 4
Public Version Date: 2019-06-07
Public Version Status: Update
Public Device Record Key: 2dd19c8a-faa9-4096-b0e6-8080a2a3dfc0

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

GMDN Terms

Code	Name	Definition	Implantable	Status
61952	Frame/rail/pole device holder	A clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682120104	GS1

Premarket Submissions

Submission Number	Supplement Number
K043551	000

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal
Type: Handling Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 105 KiloPascal
Type: Storage Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity