OrthoVAC

Basic Information

• Brand Name: OrthoVAC
• Primary DI: 20653405986352
• Version / Model: 0037001
• Catalog Number: 0037001
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-10-05
• Public Version: 1
• Public Version Date: 2021-10-13
• Public Version Status: New
• Public Device Record Key: 346f8efc-e0ed-4ee3-9751-2b00614c652a

Device Description

OrthoVAC Orthopedic Yankauer Kit: 6 mm Yankauer, 11/32" (9 mm) x 12' (3.7 m) clear tubing and adapters

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
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	30653405986359	GS1	BOX	1	In Commercial Distribution
Primary	20653405986352	GS1
Unit of Use	00653405986358	GS1

Customer Contacts

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

Storage Conditions

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