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| 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 |
| 07290016991086 | The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumerati |
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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