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PAINfusor Catheter

FDA UDI

Class II (US FDA UDI)

by Plan 1 Health, S.R.L.

Identity

Trade Name
PAINfusor Catheter FDA UDI
Generic Name
Anaesthesia conduction catheterization kit FDA UDI
Device Name
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. FDA UDI
Model / Reference
2.5 cm - 1" FDA UDI
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. FDA UDI

Identifiers

Catalog Number
203.06.10.02US FDA UDI
Primary DI / UDI-DI
08056459671218 FDA UDI
510(k) Number
K111031 FDA UDI
FDA Product Code
BSO FDA UDI
GMDN Term
Anaesthesia conduction catheterization kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 2.5 Centimeter FDA UDI
Length — 1 Inch FDA UDI

Category: Anaesthesia conduction catheterization kit

PAINfusor Catheter by Plan 1 Health, S.R.L. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia conduction catheterization kit.

Cleared under the same submission

K111031 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Plan 1 Health, S.R.L.

Sources (1)

  • FDA UDI f889869c-aa6c-4686-9d5b-d4abed1c287b 37 fields · synced May 30, 2026