FILTER

Basic Information

• Brand Name: FILTER
• Primary DI: 04048223050064
• Version / Model: 001163-39F
• Catalog Number: 001163-39F
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-04-02
• Public Version: 1
• Public Version Date: 2021-04-12
• Public Version Status: New
• Public Device Record Key: 7b60ac88-f86f-4f0c-8fb2-6a9335b9dd64

Device Description

001163-39F

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSN	FILTER, CONDUCTION, ANESTHETIC	Anesthesiology	868.5130	2

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
Unit of Use	04048223041796	GS1
Previous	14048223041793	GS1
Primary	04048223050064	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190663	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 65 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius