NovaLine
NovaLine model 956007 is identified in the FDA filing as a single-use transducer protector for hemodialysis delivery systems. Its stated purpose is to protect pressure monitors and help…
NovaLine model 956007 is identified in the FDA filing as a single-use transducer protector for hemodialysis delivery systems.
Its stated purpose is to protect pressure monitors and help prevent contamination of the system fluid pathway.
Construction and Placement
The device has a plastic housing with a hydrophobic filter and male and female luer lock connectors. The filing describes it as attaching between a blood tubing set and a hemodialysis machine pressure monitor.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Bain Medical Equipment(Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
| Vital Healthcare (Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Bain Medical Equipment(Guangzhou) Co., Ltd., China |
|---|---|
| FDA product code | FIB |
| Device type | Protector, Transducer, Dialysis |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5820 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K240164 |
| Record published | 2024-07-31 |
| Record revised | 2025-08-07 (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, manufacturing date |
| Packaging | Pack of 60, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 956007 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Molded Products, Inc. | Molded Products Inc. | 2 |
| Dualex Transducer Protector | Merck Millipore Ltd. | 2 |
| Dualex Plus Transducer Protector | Merck Millipore Ltd. | 2 |
| Millex – FH | Merck Millipore Ltd. | 2 |
| Dualex Ultra Transducer Protector | Merck Millipore Ltd. | 2 |
| Hydromillex | Merck Millipore Ltd. | 2 |
| Fresenius | Fresenius Medical Care | 1 |
| Pall | Pall International Sàrl | 1 |
| ViraGuard Viral Blocking Patient Transducer Protector | Medisystems Corp. | 1 |
| Nipro TP-Sure | Nipro Medical Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240164 | 2024-06-28 |
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.