NA

Basic Information

• Brand Name: NA
• Primary DI: 00858965006755
• Version / Model: TAL151
• Catalog Number: NA
• Company Name: PAJUNK MEDICAL SYSTEMS, LP
• Labeler DUNS: 136718553
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-20
• Public Version: 3
• Public Version Date: 2023-12-15
• Public Version Status: Update
• Public Device Record Key: 040b3faa-5b8e-4ade-99cc-c3819cd370d7

Device Description

EpiLong Soft Tray 17G x 3.5" (90mm) needle with 1cm graduation, plastic stylet and wings, EpiLong Soft 19G x 35'' (90cm) catheter with closed tip and 6 lateral openings (CONTINUOUS EPIDURAL)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
OGE	Epidural Anesthesia Kit	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61911	Epidural anaesthesia set, medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20858965006759	GS1	NA	10	In Commercial Distribution
Primary	00858965006755	GS1

Customer Contacts

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