DeVilbiss

Basic Information

• Brand Name: DeVilbiss
• Primary DI: 00853040026352
• Version / Model: 535D-E-870
• Catalog Number: 535D-E-870
• Company Name: DEVILBISS HEALTHCARE LLC
• Labeler DUNS: 962175894
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 5
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: 64e60ec6-ce52-4035-8a0d-64c44740d87a
• Distribution End Date: 2016-09-09

Device Description

E CYL W/IFILL POST ADAPTER, W/870 POST VALVE

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
CAW	Generator, Oxygen, Portable	Anesthesiology	868.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31760	Fixed-regulator oxygen refillable cylinder	A container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853040026352	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053240	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius