Duns Number:541972329
Device Description: The PAINfusor Catheter, along with related accessory devices, is intended for use to prov 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.
Catalog Number
203.06.10.30US
Brand Name
PAINfusor Catheter
Version/Model Number
30 cm - 12"
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111031,K111031
Product Code
BSO
Product Code Name
Catheter, Conduction, Anesthetic
Public Device Record Key
14627a7d-743e-4280-9996-f0c453e15e5e
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
18056459671253
Quantity per Package
12
Contains DI Package
08056459671256
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box