Resp-O2 Aerosol Drainage Bag

Basic Information

• Brand Name: Resp-O2 Aerosol Drainage Bag
• Primary DI: 00840117311992
• Version / Model: 34201
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-22
• Public Version: 1
• Public Version Date: 2021-04-30
• Public Version Status: New
• Public Device Record Key: e828f586-3cea-433a-98f7-4113b671b050

Device Description

Resp-O2 Aerosol Drainage Bag with T-Adaptor, 750 cc; Accepts Standard 22mm ID Corrugated Tubing

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: MR Safe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYH	Drain, Tee (Water Trap)	Anesthesiology	868.5995	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58337	Thermal vapour lung treatment system drainage bag	A non-sterile plastic pouch intended to collect the effluent (water) from a thermal vapour lung treatment system generator after the water vapour has cooled and condensed. It typically has tabs for attachment to the generator trolley. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840117312005	GS1	Case	50	In Commercial Distribution
Primary	00840117311992	GS1