RESMED

Basic Information

• Brand Name: RESMED
• Primary DI: 00619498339631
• Version / Model: 33963
• Catalog Number: 33963
• Company Name: RESMED PTY LTD
• Labeler DUNS: 751149311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 3
• Public Version Date: 2021-07-23
• Public Version Status: Update
• Public Device Record Key: c24786b1-c8e3-45a0-bced-9b4054077a37

Device Description

TUBING WRAP

Device Characteristics

• Single Use: No
• 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: 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
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61444	Respiratory thermal shield	A non-sterile cover intended to be fitted to the outside of a ventilator/respiratory device component (e.g., breathing circuit sensor) to provide thermal insulation, typically for the reduction of condensate within the parent device. It is typically a piece of moulded synthetic polymer shaped to fit over the appropriate respiratory device component. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00619498339631	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit