XLR8 Canister
The XLR8 canister collects fluid removed from a wound during negative pressure wound therapy with the compatible XLR8 wound vacuum system. It is the collection accessory for the suction…
The XLR8 canister collects fluid removed from a wound during negative pressure wound therapy with the compatible XLR8 wound vacuum system. It is the collection accessory for the suction pump and dressing arrangement.
The disposable canister incorporates a hydrophobic shutoff filter for overflow protection. As wound exudate enters the collection container, the filter forms part of the system’s protection against fluid overflow.
Listed Item
All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates.
Canister Options
The XLR8 Plus system uses disposable canisters in 200, 400, 600, 800 and 1,100 mL capacities. The canisters are supplied nonsterile and are not reusable.
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shanghai ISO Medical Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Devon Medical Products (Jiangsu) Ltd | Nantong | Jiangsu | Repacker / relabeller | 12 |
| Nantong MedTech Medical Products Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Lightstone Medical Products (Ningbo) Co Ltd | Ningbo | Zhejiang | Specification developer | 3 |
Record
| Listed by | Genadyne Biotechnologies, Inc., United States |
|---|---|
| FDA product code | OMP |
| Device type | Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K143726 |
| Record published | 2024-08-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4-S00D8 | In distribution | |
| A4-S00D4 | In distribution | |
| A4-S00D11 | In distribution | |
| A4-S00D6 | In distribution | |
| A4-S00D2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 57 |
| Pico | Smith & Nephew, Inc. | 57 |
| Negative Pressure Wound Therapy Powered Suction Pump | Carilex Medical, Inc. | 43 |
| DeRoyal | Deroyal Industries, Inc. | 34 |
| extriCARE | Oakwell Distribution, Inc. | 32 |
| Renasys | Smith & Nephew, Inc. | 27 |
| MicroDoc Npwt System | Pensar Medical | 26 |
| ExtriCARE | Alleva Medical Ltd | 22 |
| Vcare Alpha | I.V.T. Medical Ltd | 19 |
| V.A.C.® Granufoam™ | KCI USA, Inc. | 19 |
| Avance | Mölnlycke Health Care AB | 18 |
| Avance® Solo | Mölnlycke Health Care AB | 17 |
Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253429 | 2026-03-12 |
| K233614 | 2024-12-23 |
| K221888 | 2023-06-12 |
| K221891 | 2022-12-14 |
| K210107 | 2022-06-01 |
| K190028 | 2020-01-15 |
| K182722 | 2019-09-27 |
| K180840 | 2018-11-30 |
| K161599 | 2017-04-06 |
| K143726 | 2015-06-19 |
| K142646 | 2015-04-30 |
| K141961 | 2015-03-26 |
| K141437 | 2014-09-19 |
| K092992 | 2010-06-29 |
| K090638 | 2009-04-29 |
| K082676 | 2008-12-18 |
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.