RespArray Temperature probe

GUDID 06944413839502

Edan Instruments, Inc.

General-purpose patient temperature probe, reusable
Primary Device ID06944413839502
NIH Device Record Key12ff3e1b-5097-4cb6-82e3-81d592bab0a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespArray Temperature probe
Version Model Number02.57.225246
Company DUNS529173163
Company NameEdan Instruments, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413839502 [Primary]
GS116944413839509 [Package]
Package: [10 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-29
Device Publish Date2024-04-19

On-Brand Devices [RespArray Temperature probe]

0694441382473701.15.040551
0694441383953302.57.225245
0694441383952602.57.225243
0694441383951902.57.225244
0694441383950202.57.225246

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