E-Cath® II Tsui® NRFit

Basic Information

• Brand Name: E-Cath® II Tsui® NRFit
• Primary DI: 04048223121702
• Version / Model: 301265-40E
• Catalog Number: 301265-40E
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-30
• Public Version: 1
• Public Version Date: 2025-02-07
• Public Version Status: New
• Public Device Record Key: e05d1795-340b-489c-89b4-2a150e50d827

Device Description

E-Cath® II Tsui® NRFit SonoPlex® II Facet S NRFit 21G with indwelling catheter 18G x 50mm

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: MR Unsafe
• 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
BSO	CATHETER, CONDUCTION, ANESTHETIC	Anesthesiology	868.5120	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	04048223121719	GS1		10	In Commercial Distribution
Primary	04048223121702	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152952	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	18.0	Gauge
Length	50.0	Millimeter

Storage Conditions

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