TRACOE® care

Basic Information

• Brand Name: TRACOE® care
• Primary DI: 04035324059812
• Version / Model: REF 936
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 26da42ed-724e-4be4-b17c-c977ae5618b8

Device Description

TRACOE tube clean Cleaning swabs large

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
KXF	APPLICATOR, ABSORBENT TIPPED, NON-STERILE	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58718	Tracheostomy tube cannula cleaning swab, non-sterile	A non-sterile device intended to be used to clean the inner cannula of a tracheostomy tube that has been removed from the in situ tracheostomy tube. It typically consists of a flexible shaft, which in itself can act as a handle, with a swab made of foam or bristles at the distal end. It is used by a patient or healthcare provider to remove secretions from the inside of the inner cannula. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035324059812	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Overall length: 150 mm Diameter of sponge: 7.9 mm

Storage Conditions

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