GPS® III Platelet Concentration System
4 catalogue numbers from 800-1003A, listed by Biomet Biologics, LLC, under Supplies, Blood-Bank. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Lilian Precision Mould Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Goju Identification Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Biomet Biologics, LLC |
|---|---|
| FDA product code | KSS |
| Device type | Supplies, Blood-Bank |
| Device class | Class 1 |
| Regulation | 21 CFR 864.9050 |
| 510(k) | BK070026 |
| Record published | 2018-11-13 |
| Record revised | 2025-05-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 800-1003A | 60 mL | In distribution | |
| 800-1004A | 60 mL | In distribution | |
| 800-1007A | 30 ML | 6 | In distribution |
| 800-1006A | 60 ML | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rad-Sure™ | Ashland Specialty Ingredients, G.P. | 20 |
| RadTag | Radtag Technologies, Inc. | 12 |
| Cascade | Musculoskeletal Transplant Foundation | 5 |
| MTS | Micro Typing Systems, Inc. | 5 |
| Capture Liss | Immucor, Inc. | 5 |
| MacoPress Smarter | Delcon SRL | 4 |
| Marketlab Inc | Marketlab Incorporated | 4 |
| Capture-P | Immucor, Inc. | 3 |
| GPS® III | Biomet Biologics, LLC | 2 |
| Typesafe 2.0 | Typenex Medical, LLC | 2 |
| Capture-P Indicator Red Cells | Immucor, Inc. | 2 |
| Typesafe | Typenex Medical, LLC | 2 |
Showing 12 of 48. All products under Supplies, Blood-Bank
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.