FDA.reportPublic FDA data

TELIGEN

Primary DI
10705034599861
Brand
TELIGEN
Company
Medos International Sàrl
Model
286007083
Catalog number
286007083
Device description
TELIGEN CART ASSEMBLED
Published
2023-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZNCART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
KQMCAMERA, SURGICAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Anesthesiology1
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034599861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503459986110705034599861

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light mountA permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034581835ROBOTIC INTEGRATION INSTRUMENTS2914-89-0012914890012025-04-17
10705034581842ROBOTIC INTEGRATION INSTRUMENTS2914-89-0022914890022025-04-17
10705034602349ROBOTIC INTEGRATION INSTRUMENTS2914-89-4032914894032025-04-17
10705034602424ROBOTIC INTEGRATION INSTRUMENTS2914-89-4012914894012025-04-17
10705034602462ROBOTIC INTEGRATION INSTRUMENTS2914-89-0002914890002025-04-17
10705034643243VELYS4516110384516110382025-03-28
10705034643250VELYS4516110504516110502025-03-28
10705034643274VELYS4516110214516110212025-03-28
10705034643281VELYS4516110554516110552025-03-28
10705034643298VELYS4516110474516110472025-03-28
10705034643304VELYS4516110464516110462025-03-28
10705034643328VELYS4516110404516110402025-03-28
10705034643342VELYS4516110624516110622025-03-28
10705034643359VELYS4516110454516110452025-03-28
10705034643366VELYS4516110444516110442025-03-28
10705034643373VELYS4516110434516110432025-03-28
10705034643380VELYS4516110414516110412025-03-28
10705034643397VELYS4516110614516110612025-03-28
10705034643403VELYS4516110224516110222025-03-28
10705034643410VELYS4516110234516110232025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840178704863ITDTouchpoint Medical, Inc.BZN2026-08-03
10197344213627MEDLINEMEDLINE INDUSTRIES, INC.KQM2026-07-20
00840178704122ITDTouchpoint Medical, Inc.BZN2026-07-07
00819761023117Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
00819761023124Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
04995047074885CuratOREIZO CORPORATIONKQM2026-06-24
00840456206768JMUJMU DENTAL, INCBZN2026-06-23
00840456206775JMUJMU DENTAL, INCBZN2026-06-23
00840178704801ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704818ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704825ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704832ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704849ITDTouchpoint Medical, Inc.BZN2026-06-10
00819761023063Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023087Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023094Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-04
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
G035X1BT70M0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2026-04-28
G035001LMFX30MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2025-11-10
G035001SCX1T0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2025-09-10
G035009SCACC0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2025-09-10
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20