Plastic Intake Nebulizer Filters - with Heads

Basic Information

• Brand Name: Plastic Intake Nebulizer Filters - with Heads
• Primary DI: 00848530010102
• Version / Model: BF016
• Catalog Number: BF016
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 2
• Public Version Date: 2018-08-15
• Public Version Status: Update
• Public Device Record Key: 3ff9f2cf-1cb7-49fc-ba0b-9fe88ae1dda9

Device Description

Plastic Intake Nebulizer Filters - with Heads

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
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
Package	10848530010109	GS1		3000	In Commercial Distribution
Primary	00848530010102	GS1
Unit of Use	20848530010106	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Large