Resp-O2 Yankauer Suction Handle

Basic Information

• Brand Name: Resp-O2 Yankauer Suction Handle
• Primary DI: 00840117313712
• Version / Model: 32128
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-21
• Public Version: 2
• Public Version Date: 2023-11-23
• Public Version Status: Update
• Public Device Record Key: cad268ec-ba8d-402e-b591-d51ced972ede

Device Description

Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented w/Pre-Attached 1/4" x 10' Suction Tubing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAZ	Tubing, Noninvasive	General Hospital	880.6740	2
JOL	Catheter And Tip, Suction	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
66598	Surgical/emergency suction handle	A noninvasive, non-powered, hand-held device intended to be connected to, and facilitate manipulation of, an appropriate cannula/tip (not included) for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction (e.g., meconium); it is not intended for irrigation. It is in the form of a cylinder with an inner lumen which includes a side-hole for low-level suction control (e.g., using the thumb); it does not incorporate a switch(es), valve(s) or button(s). It may include connection tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840117313712	GS1
Package	00840117313705	GS1	Case	20	In Commercial Distribution