XN CAL PF

GUDID 14987562460356

XN CAL PF 5X3.0ML

SYSMEX CORPORATION

Full blood count IVD, calibrator
Primary Device ID14987562460356
NIH Device Record Keyd279d739-dd41-4136-9d43-621133e3953c
Commercial Distribution StatusIn Commercial Distribution
Brand NameXN CAL PF
Version Model Number213537
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com

Device Dimensions

Total Volume3 Milliliter
Total Volume3 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS114987562460356 [Primary]

FDA Product Code

KRXCALIBRATOR FOR CELL INDICES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-18
Device Publish Date2017-10-06

On-Brand Devices [XN CAL PF]

14987562460356XN CAL PF 5X3.0ML
14987562460349XN CAL PF 1X3.0ML

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