HemoScreen BC-MA-00100
GUDID 17290016991076
A disposable unit used for the collection of the blood sample
PIXCELL MEDICAL TECHNOLOGIES LTD
Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA Capillary blood collection tube IVD, K2EDTA| Primary Device ID | 17290016991076 |
| NIH Device Record Key | 72c53a76-ff77-4d5a-83c3-d5c989c361ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemoScreen |
| Version Model Number | CBC Sampler |
| Catalog Number | BC-MA-00100 |
| Company DUNS | 532623092 |
| Company Name | PIXCELL MEDICAL TECHNOLOGIES LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 17 Degrees Celsius and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016991079 [Primary] |
| GS1 | 17290016991076 [Package] Contains: 07290016991079 Package: Catron or aluminum [10 Units] In Commercial Distribution |
| GS1 | 27290016991073 [Package] Contains: 07290016991079 Package: Aluminum bag [25 Units] In Commercial Distribution |
| GS1 | 37290016991070 [Package] Contains: 07290016991079 Package: Carton Box [100 Units] Discontinued: 2022-10-06 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180020
FDA Product Code
| GKZ | Counter, Differential 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 | 2022-07-27 |
| Device Publish Date | 2022-07-19 |
On-Brand Devices [HemoScreen]
| 07290016991048 | A disposable unit used for the collection of the blood sample |
| 07290016991024 | A self-contained disposable unit in which a single blood sample is prepared and made ready for m |
| 07290016991000 | The HemoScreen is a quantitative automated hematology analyzer intended for in vitro diagnostic |
| 17290016991076 | A disposable unit used for the collection of the blood sample |
Trademark Results [HemoScreen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOSCREEN 79169295 not registered Dead/Abandoned |
PIXCELL MEDICAL TECHNOLOGIES LTD 2015-05-06 |
 HEMOSCREEN 74229798 not registered Dead/Abandoned |
FUJISAWA PHARMACEUTICAL CO., LTD. 1991-12-12 |
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