Primary Device ID | 07290016991062 |
NIH Device Record Key | 6789013f-3d97-4c98-ab4d-3e5fb800a068 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HemoCup |
Version Model Number | HemoCup |
Company DUNS | 532623092 |
Company Name | PIXCELL MEDICAL TECHNOLOGIES LTD |
Device Count | 100 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07290016991055 [Unit of Use] |
GS1 | 07290016991062 [Primary] |
LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-04 |
Device Publish Date | 2019-05-27 |
07290016991086 - HemoScreen | 2024-09-10 The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the fol |
17290016991076 - HemoScreen | 2022-07-27 A disposable unit used for the collection of the blood sample |
07290016991000 - HemoScreen | 2019-12-23 The HemoScreen is a quantitative automated hematology analyzer intended for in vitro diagnostic point-of-care (POC) use to class |
07290016991024 - HemoScreen | 2019-12-23 A self-contained disposable unit in which a single blood sample is prepared and made ready for measurement and CBC analysis |
07290016991048 - HemoScreen | 2019-12-23 A disposable unit used for the collection of the blood sample |
07290016991062 - HemoCup | 2019-06-04A disposable unit used for dispensing blood from a test tube. |
07290016991062 - HemoCup | 2019-06-04 A disposable unit used for dispensing blood from a test tube. |