Digital Thermometer - Flexible Tip

GUDID 00616784561134

DYNAREX CORPORATION

Intermittent electronic patient thermometer
Primary Device ID00616784561134
NIH Device Record Key509ddea4-1abc-438c-b0b5-2a290bdfcbcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital Thermometer - Flexible Tip
Version Model Number5611
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784561110 [Primary]
GS100616784561127 [Package]
Contains: 00616784561110
Package: [12 Units]
In Commercial Distribution
GS100616784561134 [Package]
Contains: 00616784561127
Package: [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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