Tecotherm

Basic Information

• Brand Name: Tecotherm
• Primary DI: 05060206921740
• Version / Model: TC-CRS
• Company Name: INSPIRATION HEALTHCARE LIMITED
• Labeler DUNS: 734903532
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-07
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 157ac857-39dc-4052-800d-6f2a39e7228b

Device Description

TC-CRS Fill-up set for Serial numbers 2015/24/01 and higher

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPF	BOTTLE, HOT/COLD WATER	General Hospital	880.6085	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42841	Intravenous/irrigation solution storage container, reusable	An empty glass or plastic receptacle, capable of being sterilized, intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060206921740	GS1

Customer Contacts

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