Soaking Cup
Endocavity soaking cup kit with polyethylene cup, lid, funnels (2) and mounting hardware
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
Record
| Listed by | Civco Medical Instruments Co., Inc., United States |
|---|---|
| FDA product code | PHT |
| Device type | Basin For Endoscope Reprocessing |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-23 |
| Record revised | 2023-04-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 610-584 | In distribution | |
| 610-585 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BR Surgical, LLC | BR Surgical LLC | 26 |
| GUS | Civco Medical Instruments Co., Inc. | 10 |
| CeroFrict | SML MED-Tech Solutions Limited | 5 |
| Basin For Endoscope Reprocessing | Richard Wolf Gmbh | 3 |
| Revital-Ox | Steris Corporation | 2 |
| Disinfecting Container | Civco Medical Instruments Co., Inc. | 1 |
| ECO EZ Cleanse | Meditech Endoscopy Ltd | 1 |
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.