Curaplex
Curaplex Fluid Spill Kit
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
Record
| Listed by | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | PXG |
| Device type | Spill Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6890 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-15 |
| Record revised | 2022-08-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 30, case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 29310-S | In distribution | |
| 290025 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MedStream | Medical Specialties Distributors, Inc. | 8 |
| Stradis Medical, LLC. | Stradis Healthcare | 4 |
| Stradis Healthcare, LLC | Stradis Healthcare | 2 |
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.