Tubing and Tubing/Filter Fits
Tubing set for HYS E.A.S.I.,URO E.A.S.I.
1manufacturer
8catalogue numbers in this listing
Who Else Makes It
Registered in Anhui.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
Record
| Listed by | Karl Storz GmbH & Co. KG |
|---|---|
| FDA product code | NVT |
| Device type | Tubing And Tubing/Filter Fits |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1700 |
| Premarket notification | Exempt |
| Record published | 2019-02-23 |
| Record revised | 2024-07-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 030247-10 | 10 | In distribution | |
| 031717-10 | 10 | In distribution | |
| 031117-10 | 10 | In distribution | |
| 031523-10 | 10 | In distribution | |
| 031317-10 | 10 | In distribution | |
| 031118-10 | 10 | In distribution | |
| 031417-10 | 10 | In distribution | |
| 031135-10 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 4 |
| Rocket | Rocket Medical PLC | 3 |
| LiNA OperaScope™ Tubing & Drape kit | LiNA Medical AG | 3 |
| ThermaClear | Stryker GmbH | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2024-10-21 | Class II | Labeling design | Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S. | 40 units |
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.