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
Primary Device ID04987562020171
NIH Device Record Keye3de793f-e3ea-44ba-bd39-05ed8d0fd1ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameCELLPACK
Version Model Number88408915
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com

Device Dimensions

Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter
Total Volume10 Liter

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987562020171 [Primary]

FDA Product Code

GIFDiluent, Blood Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

On-Brand Devices [CELLPACK]

00664369204518Whole blood diluent for use in hematology analyzers
00664369020101Whole blood diluent for use in hematology analyzers
04987562020171CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dyna
04987562020102CELLPACK 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
CELLPACK
79405424 not registered Live/Pending
Behr Bircher Cellpack BBC AG
2024-08-21
CELLPACK
CELLPACK
79012427 3209313 Dead/Cancelled
CELLPACK AG
2005-05-10
CELLPACK
CELLPACK
75299876 2162082 Live/Registered
SYSMEX CORPORATION
1997-05-15

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