Bacteria Filter

Basic Information

• Brand Name: Bacteria Filter
• Primary DI: 00848530010645
• Version / Model: BF516TS
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-06-20
• Public Version: 2
• Public Version Date: 2026-01-12
• Public Version Status: Update
• Public Device Record Key: a4ca0a7a-7203-43ba-99cc-e82b5eac73c4

Device Description

Final Bacteria Filter Suction Inlet 1/4 to 3/8 Threaded - 10/Pack

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	868.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31245	Local/regional anaesthesia conduction filter	A microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during subcutaneous administration to a patient (e.g., through a spinal or epidural catheter); it may in addition be intended for use during medication administration or preparation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10848530010642	GS1
Primary	00848530010645	GS1

Customer Contacts

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