TRACOE® care

Basic Information

• Brand Name: TRACOE® care
• Primary DI: 04035324061112
• Version / Model: REF 934
• Company Name: Tracoe medical GmbH
• Labeler DUNS: 319414785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-17
• Public Version: 1
• Public Version Date: 2023-06-26
• Public Version Status: New
• Public Device Record Key: cf4ccb72-30d4-47ff-a189-d6d89647c64b

Device Description

TRACOE tube clean Cleaning tub

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OGV	Tracheostomy Cleaning Tray	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62628	Artificial airway washing/disinfection jar	A container designed to hold artificial airway devices [e.g., endotracheal tube (ET), tracheostomy tube, laryngeal airway] to facilitate their washing/disinfection. It is made of a sterilizable material (e.g., high-grade stainless steel, plastic) and is designed to be filled with a cleaning/disinfecting solution while in use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035324061112	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Volume: 1000 ml

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: no special storage conditions