ViraGuard Viral Blocking Patient Transducer Protector
Catalogue number M8-2006, listed by Medisystems Corp., United States, under Protector, Transducer, Dialysis. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
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 | Medisystems Corp., United States |
|---|---|
| FDA product code | FIB |
| Device type | Protector, Transducer, Dialysis |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5820 |
| Record published | 2015-09-01 |
| Record revised | 2025-08-07 (version 3) |
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 |
| Storage | Special storage condition: Proect from moisture, freezing and excessive heat |
| Packaging | Pack of 300 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M8-2006 | 100 | 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 |
| NovaLine | Bain Medical Equipment(Guangzhou) Co., Ltd. | 1 |
| Nipro TP-Sure | Nipro Medical Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K983076 | 1998-11-25 |
| K970536 | 1997-05-12 |
| K895856 | 1989-11-24 |
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.