Resp-O2 Suction Catheter Kit 10 FR Mini Tray

Basic Information

• Brand Name: Resp-O2 Suction Catheter Kit 10 FR Mini Tray
• Primary DI: 00840117313477
• Version / Model: 32081
• 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: 1
• Public Version Date: 2022-04-29
• Public Version Status: New
• Public Device Record Key: e679dfb4-69a3-4bab-a1f0-754df6cafe44

Device Description

Resp-O2 Suction Catheter Kit, 10 FR Mini-Tray Contents: 1 One-Compartment Mini-Tray 1 Adult Graduated Catheter with Control Valve 1 Pair of Powder-Free Vinyl Exam Gloves

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
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13846	Secretion suction kit	A collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840117313477	GS1
Package	00840117313460	GS1	Case	100	In Commercial Distribution