SP
Certified Blood Bank Saline; Stabilized Isotonic Saline; Contains No Preservatives; For In Vitro Diagnostic Use Only; Not for Infusion, Injection, or Irrigation; 10 liters
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | GIF |
| Device type | Diluent, Blood Cell |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8200 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-27 |
| Record revised | 2020-01-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 4 |
| Distribution end date | 2020-01-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B3158-3 | Withdrawn | |
| B3158-2 | Withdrawn | |
| B3158-1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cell-DYN | Abbott Laboratories | 7 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Cellpack | Sysmex Corporation | 4 |
| Cellpack DST | Sysmex Corporation | 4 |
| Drew Scientific | Drew Scientific, Ltd. | 3 |
| Atellica IM Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| Cellpack DCL | Sysmex Corporation | 3 |
| Needle Holder | Koros U.S.A., Inc. | 3 |
| Advia Centaur® Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| UF II Pack-SED | Sysmex Corporation | 2 |
| Cellsheath | Sysmex Corporation | 2 |
| UF-Cellpack CR | Sysmex Corporation | 2 |
Showing 12 of 88. All products under Diluent, Blood Cell
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.