N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00858965006762
• Version / Model: TDLC207
• Company Name: PAJUNK MEDICAL SYSTEMS, LP
• Labeler DUNS: 136718553
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-21
• Public Version: 2
• Public Version Date: 2024-01-18
• Public Version Status: Update
• Public Device Record Key: 55052793-b6c4-43b2-8389-78045b5a96b4

Device Description

Custom E-Cath Tray 18G x 2'' (51mm) indwelling catheter, SonoPlex 21G x 2 2/3'' (68mm) echogenic needle with distal opening, E-Cath 20G echogenic Self-Priming catheter with open tip and fixed injection tubing, FixoCath catheter fixation device and Safersonic Probe Cover & Gel [10/box]

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: Yes
• 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
OGJ	Nerve Block Tray	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64347	Peripheral anaesthesia catheter set, medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent, an anaesthesia catheter, and an anaesthesia needle 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	20858965006766	GS1		10	In Commercial Distribution
Primary	00858965006762	GS1

Customer Contacts

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