CUSTOMED

Basic Information

• Brand Name: CUSTOMED
• Primary DI: M20890030090
• Version / Model: 712057143009
• Catalog Number: 9003009
• Company Name: CUSTOMED INC
• Labeler DUNS: 627572217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: bb40d69a-c9e0-4b3a-950c-375877d73b77

Device Description

ENDOTRACHEAL TUBE, CUFFED, SIZE: 6.0MM

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46967	Basic endotracheal tube, single-use	A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M20890030090	HIBCC
Package	M20890030091	HIBCC	10/BOX	10	In Commercial Distribution
Package	M20890030092	HIBCC	10/BOX 10BOX/CS	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042683	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	6.0	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use lubricant with petroleum base.
• Type: Special Storage Condition, Specify
• Special Conditions: Store in clean, cool, and dry place, avoid heat and light.