FDA.reportPublic FDA data

Ergon Boom Series

Primary DI
10841736100896
Brand
Ergon Boom Series
Company
SKYTRON LLC
Model
Ergon 3
Catalog number
330 Series
Device description
Tandem Mount with optional surgical or exam lighting.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZFDEVICE, MEDICAL EXAMINATION, AC POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZFDevice, Medical Examination, Ac PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736100896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173610089610841736100896

GMDN Terms#

Term, Definition table
TermDefinition
General utility supply system, ceiling-mountedAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)759-8766info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736124410Skytron 200 x 400 VESA Adapter Plate4A-VESA-200-400 Freedom4A-VESA-200-4002026-03-19
10841736125141CleanStartCSTART-7115CSTART-71152025-12-19
10841736125158CleanStartCSTART-7130CSTART-71302025-12-19
10841736125165CleanStartCSTART-8115CSTART-81152025-12-19
10841736125172CleanStartCSTART-8130CSTART-81302025-12-19
10841736125189CleanStartCSTART-8315CSTART-83152025-12-19
10841736125196CleanStartCSTART-8330CSTART-83302025-12-19
10841736125202CleanStartCSTART-9815CSTART-98152025-12-19
10841736125219CleanStartCSTART-9830CSTART-98302025-12-19
10841736124298Skytron LLC40-LC-ED40-LC-ED2025-12-09
10841736124427Sterling 1000-MIS-WA1000-MIS-WA2025-12-09
10841736124434Sterling 1800-MIS-WA1800-MIS-WA2025-12-09
10841736124861Skytron4-030-42-94-030-42-92025-12-03
10841736124878Skytron1-012-04-21-012-04-22025-12-03
10841736124885Skytron1-012-04-31-012-04-32025-12-03
10841736124892Skytron1-012-04-41-012-04-42025-12-03
10841736124908Skytron1-012-04-51-012-04-52025-12-03
10841736124915Skytron2-060-05-3S2-060-05-3S2025-12-03
10841736124939Skytron4-030-01-14-030-01-12025-12-03
10841736124946Skytron4-030-10-2WS4-030-10-2WS2025-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995244293HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244354HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244361HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244385HexaLuxSTERIS CORPORATIONKZF2025-05-05
04250365155471ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155488ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155495ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155839ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155860ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174434ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174441ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365175530ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365189797ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
00724995225070NASTERIS CORPORATIONKZF2024-11-25
00724995225179NASTERIS CORPORATIONKZF2024-11-25
00724995225186NASTERIS CORPORATIONKZF2024-11-25
00724995225667NASTERIS CORPORATIONKZF2024-11-25
00724995225674NASTERIS CORPORATIONKZF2024-11-25
00724995225087NASTERIS CORPORATIONKZF2024-11-07
00724995225094NASTERIS CORPORATIONKZF2024-11-07
03700712434373LUCEA LED®MAQUET SASKZF2024-10-15
03700712434380LUCEA LED®MAQUET SASKZF2024-10-15
03700712434397LUCEA LED®MAQUET SASKZF2024-10-15
03700712434403LUCEA LED®MAQUET SASKZF2024-10-15
03700712434410LUCEA LED®MAQUET SASKZF2024-10-15
03700712434427LUCEA LED®MAQUET SASKZF2024-10-15
00810115633235VeriluxBEAR DOWN CONSULTINGKZF2024-10-07
00768533810007VeriluxBEAR DOWN CONSULTINGKZF2024-09-22
00732094049558Welch Allyn, Inc.WELCH ALLYN, INC.KZF2024-08-14
00732094219104Welch Allyn, Inc.WELCH ALLYN, INC.KZF2024-08-14