EpiLong Soft Cath

Basic Information

• Brand Name: EpiLong Soft Cath
• Primary DI: 04048223073902
• Version / Model: 041151-37R
• Catalog Number: 041151-37R
• 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: 2
• Public Version Date: 2025-12-01
• Public Version Status: Update
• Public Device Record Key: f0bb22fa-8112-4fb5-91c7-c70c51ccffec

Device Description

EpiLong Soft Cath 20G x 90cm with closed tip and 6 lateral eyes

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
CAZ	Anesthesia conduction kit	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64374	Epidural anaesthesia stand-alone catheter	A flexible tube, supplied in isolation of other devices, intended to be percutaneously introduced into the epidural space for the delivery of an anaesthetic/analgesic agent; it is not coated with an antimicrobial agent. It is intended to be introduced using an epidural needle, however neither the needle nor other procedural assistive devices are included (i.e., the catheter is sold alone and this is not an epidural set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04048223053324	GS1		10	In Commercial Distribution
Primary	04048223073902	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060311	000

Device Sizes

Type	Value	Unit	Text
Length	90.0	Centimeter
Needle Gauge	20.0	Gauge

Storage Conditions

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