Thermo Scientific Nerl®

GUDID 00845275004663

Fisher Diagnostics

Buffered isotonic saline reagent IVD
Primary Device ID00845275004663
NIH Device Record Keye04b6144-b88a-4c05-97b3-dc4467896139
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermo Scientific Nerl®
Version Model Number8505
Company DUNS183998769
Company NameFisher Diagnostics
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-528-0494
EmailTechsupport_diagnostics_mtn@thermo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845275004663 [Primary]

FDA Product Code

JCESolution, Isotonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-08
Device Publish Date2019-07-31

On-Brand Devices [Thermo Scientific Nerl®]

00845275004717JDIL5522
008452750046638505
008452750046568504
008452750043669800-3
008452750043429805

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.