TELIGEN

Basic Information

• Brand Name: TELIGEN
• Primary DI: 10705034599861
• Version / Model: 286007083
• Catalog Number: 286007083
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-01
• Public Version: 2
• Public Version Date: 2023-08-31
• Public Version Status: Update
• Public Device Record Key: f131334c-5657-4584-b1ec-05b7fb74919b

Device Description

TELIGEN CART ASSEMBLED

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
KQM	CAMERA, SURGICAL AND ACCESSORIES	General, Plastic Surgery	878.4160	1
BZN	CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)	Anesthesiology	868.6175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32245	Medical monitor/light mount	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705034599861	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 14 – 122 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Storage Environment Temperature
• Temperature Range: 14 – 122 Degrees Fahrenheit