Resp-O2 Homecare 800 cc Suction Disposable Canister Full Kit

Basic Information

• Brand Name: Resp-O2 Homecare 800 cc Suction Disposable Canister Full Kit
• Primary DI: 00840117326620
• Version / Model: 32202
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-13
• Public Version: 1
• Public Version Date: 2024-12-23
• Public Version Status: New
• Public Device Record Key: 4d77209e-457c-4784-9149-94a482b025cc

Device Description

Includes: 800 cc Canister with Float Lid, 1/3" x 6' Suction Tubing, Ridged Elbow Connector, Soft Elbow Connector, Hydrophobic Shut Off Disc, Cuttable 16" Silicone Tube

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: 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDQ	Bottle, Collection, Vacuum	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or 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	00840117326620	GS1
Package	00840117326637	GS1	Case	8	In Commercial Distribution