I.series®
4 catalogue numbers from PF96i, listed by Helmer Inc., United States, under Device, Blood Mixing And Blood Weighing. 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 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 | Helmer 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 | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-07-01 |
| Record revised | 2021-08-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2021-08-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PF96i | In distribution | |
| PF15i | Withdrawn | |
| PF48i | Withdrawn | |
| PF396i | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HemoFlow | Applied Science, Inc. | 8 |
| 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.