Expandable 15 mm x 5 inch Flex Tube

Basic Information

• Brand Name: Expandable 15 mm x 5 inch Flex Tube
• Primary DI: 00636207315458
• Version / Model: VMFLEX
• Catalog Number: VMFLEX
• Company Name: Global Life Sciences Solutions USA LLC
• Labeler DUNS: 011658242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-29
• Public Version: 6
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 651e47cf-ad9d-40cc-8bfb-061c6066bbb3

Device Description

Expandable 15 mm x 5 inch Flex tube, Non-sterile, Single Patient Use

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAH	Filter, bacterial, breathing-circuit	Anesthesiology	868.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42476	Breathing circuit catheter mount, single-use	A device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end; it may include an integrated suction port or be provided with a microbial medical gas filter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30636207315459	GS1	case	100	In Commercial Distribution
Primary	00636207315458	GS1

Customer Contacts

• Phone: [phone] ext. 5164843600
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K013093	000

Device Sizes

Type	Value	Unit	Text
Length	5	Inch