TRACOE® care

Basic Information

• Brand Name: TRACOE® care
• Primary DI: 04035324046713
• Version / Model: REF 902
• Company Name: Tracoe medical GmbH
• Labeler DUNS: 319414785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 41a1f6d6-02be-4c4b-aff3-49726d19c085

Device Description

Liquid Paraffin

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
BTO	Tube, tracheostomy (w/wo connector)	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57897	Tracheostomy tube lubricant	A non-sterile substance made of oil (e.g., paraffin) designed to be applied by healthcare staff or a patient to the outer surface of a tracheostomy tube inner cannula to facilitate its easy sliding into the outer cannula (e.g., after cleaning). The lubrication is intended to reduce frictional forces so that less physical force is required for inner cannula insertion and to help prolong the life of the tube's cannulae. It is typically available in a squeeze or dropper bottle. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035324046713	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K781729	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			25 mL oil

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The products must be stored in a cool and dry place. Temporary storage for 30 days at maximum +50 °C is possible. Protect the product from sunlight and extreme cold.