PAINfusor Catheter

Basic Information

• Brand Name: PAINfusor Catheter
• Primary DI: 08056459671249
• Version / Model: 22.5 cm - 9"
• Catalog Number: 203.06.10.22US
• Company Name: PLAN 1 HEALTH S.R.L.
• Labeler DUNS: 541972329
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 12ee0562-d6d8-4c9e-a0e8-98d83b8f92ab

Device Description

The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around a surgical wound size for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous. The PAINfusor Catheter is contraindicated for vascular or epidural drug administration for the delivery and withdrawal of dense fluids like blood, lipids and fat emulsions, and for use in neonatal population.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47191	Anaesthesia conduction catheterization kit	A collection of sterile devices and materials intended for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management. The kit consists of an anaesthesia catheter with devices dedicated to catheter introduction/function (e.g., tunneller, needle, sheath) and includes non-dedicated supportive devices (e.g., dressings, adhesive strips). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056459671249	GS1
Package	18056459671246	GS1	Carton Box	12	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K111031	000

Device Sizes

Type	Value	Unit	Text
Length	22.5	Centimeter
Length	9	Inch