Catalogue number 000451, listed by C.R. Bard, Inc., United States, under Evacuator, Gastro-Urology. 5 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Bard® Ellik Evacuator | Listed by | C.R. Bard, Inc., United States |
| FDA product code | KQT |
| Device type | Evacuator, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4370 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-08-06 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
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.