FRAZIER

Basic Information

• Brand Name: FRAZIER
• Primary DI: 40653405000113
• Version / Model: 0033080
• Catalog Number: 0033080
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-12-20
• Public Version: 1
• Public Version Date: 2022-12-28
• Public Version Status: New
• Public Device Record Key: f409e585-70fa-4bb8-9a1d-1e5bce9f320a

Device Description

FRAZIER Suction Instrument 8 Fr W/Control Vent & Obturator

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCX	APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35917	Surgical/emergency suction cannula, non-illuminating, single-use	An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10653405000112	GS1	BOX	10	In Commercial Distribution
Primary	40653405000113	GS1
Package	50653405000110	GS1	BOX	50	In Commercial Distribution
Unit of Use	00653405000122	GS1
Previous	30653405000116	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8 French Outer Diameter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius