AccessGUDID - DEVICE: PAINfusor Catheter (08056459671225)

GUDID

Device Identifier (DI) Information

Brand Name: PAINfusor Catheter
Version or Model: 7.5 cm - 3"
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 203.06.10.07US
Company Name: PLAN 1 HEALTH S.R.L.

Primary DI Number: 08056459671225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 541972329 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BSO	Catheter, Conduction, Anesthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111031	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 7.5 Centimeter
Length: 3 Inch

Device Record Status

Public Device Record Key: b73f3c87-d1a6-4b23-a87a-d045116b6166
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 23, 2016