Lumipulse G Specimen Diluent 6

GUDID 04987270234693

FUJIREBIO INC.

Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD
Primary Device ID04987270234693
NIH Device Record Key0ae054cd-104c-45de-b548-6783d1b6def4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumipulse G Specimen Diluent 6
Version Model Number234693
Company DUNS710873907
Company NameFUJIREBIO INC.
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

Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com
Phone610-240-3800
Emailcustomersupport@fdi.com

Device Dimensions

Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Right side up with care; no vibration
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987270234693 [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 Date2019-11-12
Device Publish Date2019-11-04

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