Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR

Basic Information

• Brand Name: Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR
• Primary DI: 00840117313361
• Version / Model: 36261
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-05-16
• Public Version: 1
• Public Version Date: 2022-05-24
• Public Version Status: New
• Public Device Record Key: b1db6776-4e3b-466c-bb1b-a9643555d5c5

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: No
• Has Manufacturing Date: No
• 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
KBI	Bougie, Eustachian	Ear, Nose, Throat	874.4175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41829	Endotracheal tube introducer, single-use	A device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840117313361	GS1
Unit of Use	00840117322981	GS1
Package	00840117313378	GS1	Master Shipper	20	In Commercial Distribution