TRACOE® care

Basic Information

• Brand Name: TRACOE® care
• Primary DI: 04035324012886
• Version / Model: REF 959
• Company Name: Tracoe medical GmbH
• Labeler DUNS: 319414785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-15
• Public Version: 3
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 8662263f-d7d1-4fda-ba6c-9209185f548c

Device Description

TRACOE purofoam Tracheostomy Dressing small

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing,wound,occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15624	Tracheostomy tube dressing	A pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035324012886	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6.5 x 6.5 x 0.5 cm

Storage Conditions

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