CELLPACK
GUDID 04987562020171
CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
SYSMEX CORPORATION
Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD| Primary Device ID | 04987562020171 |
| NIH Device Record Key | e3de793f-e3ea-44ba-bd39-05ed8d0fd1ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CELLPACK |
| Version Model Number | 88408915 |
| Company DUNS | 690664461 |
| Company Name | SYSMEX CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com |
Device Dimensions
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987562020171 [Primary] |
FDA Product Code
| GIF | Diluent, Blood Cell |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
On-Brand Devices [CELLPACK]
| 00664369204518 | Whole blood diluent for use in hematology analyzers |
| 00664369020101 | Whole blood diluent for use in hematology analyzers |
| 04987562020171 | CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dyna |
| 04987562020102 | CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dyna |
Trademark Results [CELLPACK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLPACK 79012427 3209313 Dead/Cancelled |
CELLPACK AG 2005-05-10 |
 CELLPACK 75299876 2162082 Live/Registered |
SYSMEX CORPORATION 1997-05-15 |
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