PAINfusor Catheter
PAINfusor is a closed-tip catheter for continuous or intermittent delivery of medication to or around a surgical wound. It is intended for preoperative, perioperative or postoperative pain…
PAINfusor is a closed-tip catheter for continuous or intermittent delivery of medication to or around a surgical wound. It is intended for preoperative, perioperative or postoperative pain management, including local anesthetic or narcotic delivery. Placement can be intraoperative or percutaneous.
A fenestrated section near the distal end contains micro-holes arranged in a helical pattern to distribute fluid along the wound. The catheter is radiopaque and has graduated markings for positional reference. Different fenestrated lengths support the described catheter configurations.
Listed Item
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.
Placement Kit
The catheter is packaged with a peel-away introducer needle, occlusive wound dressing and adhesive for securing the catheter. The needle assists placement, while the dressing and adhesive cover and stabilize the exit site. Medication flows through the catheter’s fenestrated distal section.
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | Plan 1 Health, S.R.L., United States |
|---|---|
| FDA product code | BSO |
| Device type | Catheter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| 510(k) | K111031 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton box of 12 |
| Sizes | Length 2.5 to 30 cm; length 1 to 12 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30 cm – 12″ | Length 30 cm | In distribution |
| 22.5 cm – 9″ | Length 22.5 cm | In distribution |
| 15 cm – 6″ | Length 15 cm | In distribution |
| 7.5 cm – 3″ | Length 7.5 cm | In distribution |
| 2.5 cm – 1″ | Length 2.5 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 366 |
| Epimed | Epimed International, Inc. | 56 |
| Avanos | Avanos Medical, Inc. | 48 |
| E-Cath Tsui | Pajunk Gmbh Medizintechnologie | 47 |
| Halyard | Avanos Medical, Inc. | 34 |
| Infiltralong | Pajunk Gmbh Medizintechnologie | 25 |
| E-Cath acc. Tsui | Pajunk Gmbh Medizintechnologie | 21 |
| E-Cath Plus acc. Tsui | Pajunk Gmbh Medizintechnologie | 17 |
| Epinaut | Imedicom Co., Ltd. | 16 |
| E-Cath® Plus Tsui® | Pajunk Gmbh Medizintechnologie | 10 |
| E-Cath® II Tsui® | Pajunk Gmbh Medizintechnologie | 9 |
| Spinaut-E | Imedicom Co., Ltd. | 9 |
Showing 12 of 65. All products under Catheter, Conduction, Anesthetic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111031 | 2011-07-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.