SonoLong Echo NanoLine® NRFit

Basic Information

• Brand Name: SonoLong Echo NanoLine® NRFit
• Primary DI: 04048223126691
• Version / Model: 521165-31C
• Catalog Number: 521165-31C
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-17
• Public Version: 2
• Public Version Date: 2025-06-26
• Public Version Status: Update
• Public Device Record Key: 5e5c7b97-e568-45a0-befa-9bab568ffb56

Device Description

SonoLong Echo NanoLine® NRFit SonoLong NanoLine® NRFit cannula Tuohy tip 18G x 100mm and

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: Yes
• 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
CAZ	Anesthesia conduction kit	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46383	Peripheral anaesthesia catheter set, non-medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04048223128589	GS1		10	In Commercial Distribution
Primary	04048223126691	GS1
Previous	04048223117002	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K113188	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 65 Percent (%) Relative Humidity