HemoFlow
HemoFlow 500 Basic/Blood Donation Rocker
3manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Applied Science, Inc., United States |
|---|---|
| FDA product code | KSQ |
| Device type | Device, Blood Mixing And Blood Weighing |
| Device class | Class 1 |
| Regulation | 21 CFR 864.9195 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-08 |
| Record revised | 2026-06-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature -20 to 55 °C; Storage environment humidity 10 to 90 % RH |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9-0000-0504 | In distribution | |
| 9-0000-0106 | In distribution | |
| 9-4001-0300 | In distribution | |
| 9-0000-0004 | In distribution | |
| 9-0500-0001 | In distribution | |
| 9-4000-0300 | In distribution | |
| 9-0500-0002 | In distribution | |
| 9-0000-0107 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| i.Series® | Helmer Inc. | 4 |
| Horizon Series™ | Helmer Inc. | 3 |
| Helmer | Helmer Inc. | 3 |
| Blood Collection Mixer CM735A | Centron Corporation | 1 |
| Boekel Small Platelet Agitator | Boekel Industries, Inc. | 1 |
| CompoGuard Data (NA) | Fresenius Kabi AB | 1 |
| Fresenius Kabi Adjustable Automatic Donor Scale Support Stand | Fresenius Kabi AB | 1 |
| Boekel Blood Collection Mixer | Boekel Industries, Inc. | 1 |
| Blood Collection Monitor CM350 | Centron Corporation | 1 |
| Compoguard Advance Basic | Fresenius Kabi AB | 1 |
| Data Collection Mixer DCM3000 (Basic) | Centron Corporation | 1 |
| Donor Tube Stripper | Fresenius Kabi AB | 1 |
Showing 12 of 19. All products under Device, Blood Mixing And Blood Weighing
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.