I-Tek I-150 LED Light Source

DI: 00869836000307 · Model: I-150 · I-TEK MEDICAL SOLUTIONS, INC.

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

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Basic Information

Brand Name: I-Tek I-150 LED Light Source
Primary DI: 00869836000307
Version / Model: I-150
Catalog Number: I-150
Company Name: I-TEK MEDICAL SOLUTIONS, INC.
Labeler DUNS: 080599644
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-06-23
Public Version: 2
Public Version Date: 2018-03-29
Public Version Status: Update
Public Device Record Key: 3a9a4dae-e9a3-437b-bf63-57b1e59a56df

Device Description

The LED Light Source is the light source for use with the Medical Illumination Light Enhancement System. It is a compact size with a small footprint, light, easily portable, has infinitely variable light output and is maintenance free with a long lifetime expectancy.

Device Characteristics

Single Use: No
Prescription Use (Rx): No
Over the Counter (OTC): Yes
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: Yes
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
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32037	General-purpose light source	A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869836000307	GS1

Customer Contacts

Phone: 651-454-6602
Email: [email protected]

Device Sizes

Type	Value	Unit
Width	4.65	Inch
Depth	7.25	Inch
Height	3.32	Inch
Weight	1.14	Kilogram

Storage Conditions

Type: Storage Environment Atmospheric Pressure
Temperature Range: 524.4 – 794.96 Millimeter of Mercury
Type: Handling Environment Atmospheric Pressure
Temperature Range: 524.4 – 794.96 Millimeter of Mercury
Type: Handling Environment Humidity
Temperature Range: 0 – 85 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: 32 – 104 Degrees Fahrenheit
Type: Handling Environment Temperature
Temperature Range: 0 – 40 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -4 – 140 Degrees Fahrenheit
Type: Storage Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 0 – 85 Percent (%) Relative Humidity