Healthdyne BX5000 Style Foam Cabinet Filters

Basic Information

• Brand Name: Healthdyne BX5000 Style Foam Cabinet Filters
• Primary DI: 00848530050320
• Version / Model: OF3001
• Catalog Number: OF3001
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-05-24
• Public Version: 2
• Public Version Date: 2018-08-15
• Public Version Status: Update
• Public Device Record Key: 677c4ae9-9347-498e-94be-1b61ba4a4931

Device Description

Healthdyne BX5000 Style Foam Cabinet Filters

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: 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
JRL	Unit, Filter, Membrane	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31245	Anaesthesia conduction filter	A sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530050320	GS1
Unit of Use	10848530050327	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			800cc