PAINfusor Catheter

Primary DI
08056459671232
Brand
PAINfusor Catheter
Company
PLAN 1 HEALTH S.R.L.
Model
"15 cm - 6"""
Catalog number
203.06.10.15US
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.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSOCatheter, Conduction, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111031000PAINFUSOR CATHETERPlan 1 Health, S.R.L.2011-07-08BSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056459671239PackageGS112In Commercial Distribution
08056459671232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805645967123918056459671239
08056459671232080564596712328056459671232

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction catheterization kitA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Inch
Length15Centimeter

Regulatory Flags#

DUNS number
541972329
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056459671218PAINfusor Catheter"2.5 cm - 1"""203.06.10.02US2016-09-23
08056459671225PAINfusor Catheter"7.5 cm - 3"""203.06.10.07US2016-09-23
08056459671249PAINfusor Catheter"22.5 cm - 9"""203.06.10.22US2016-09-23
08056459671256PAINfusor Catheter"30 cm - 12"""203.06.10.30US2016-09-23

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