CELLSHEATH
GUDID 04987562406005
CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex. Use as a sheath fluid for hematology analyzer.
SYSMEX CORPORATION
Buffered sample diluent IVD, automated/semi-automated system| Primary Device ID | 04987562406005 |
| NIH Device Record Key | 295cd126-b456-46d6-a6d4-ba1aa5ff8dfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CELLSHEATH |
| Version Model Number | 05404811 |
| 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 | 04987562406005 [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 [CELLSHEATH]
| 00664369020125 | Electrolytic sheath solution for use in hematology analyzers |
| 04987562406005 | CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers an |
Trademark Results [CELLSHEATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLSHEATH 75299881 2239903 Live/Registered |
SYSMEX CORPORATION 1997-05-15 |
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