Ergon Boom Series

Basic Information

• Brand Name: Ergon Boom Series
• Primary DI: 10841736100681
• Version / Model: Ergon 2
• Catalog Number: E2 320 Series
• Company Name: SKYTRON LLC
• Labeler DUNS: 078375583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 6
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 1faef76a-7a30-4d51-826b-670f1410b157

Device Description

Central Tandem Mount with Lightweight Arm with optional surgical lighting.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
FSY	Light, surgical, ceiling mounted	General, Plastic Surgery	878.4580	2
FQO	TABLE, OPERATING-ROOM, AC-POWERED	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35630	General utility supply system, ceiling-mounted	An assembly of devices that form a permanent ceiling-mounted system that provides easy access to utilities/amenities (e.g., electricity, gas, or gas scavenging). It is used in the operating room (OR), examination rooms, the recovery department, the intensive care unit (ICU), and accident and emergency (A&E) rooms. It typically consists of a ceiling fixture support, equipped with moveable arms (often multi-jointed) and a pendant head. It can include an equipment carrier for mounting other medical devices.	No	Active
42513	Transportable medical equipment stand, non-powered	A non-powered (non-active) transportable device [e.g., on wheels or easily movable] designed to support medical equipment used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment.	No	Active
37332	Operating room light system	An assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841736100681	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 14 – 140 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 14 – 140 Degrees Fahrenheit