Temp Probe

GUDID 10803622140225

LIVANOVA USA, INC.

General-purpose patient temperature probe, reusable
Primary Device ID10803622140225
NIH Device Record Keya3dc793a-6c09-4d20-a7f6-6cdd5e94a99c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTemp Probe
Version Model NumberTemp Probe
Company DUNS080914995
Company NameLIVANOVA USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100803622140228 [Primary]
GS110803622140225 [Package]
Contains: 00803622140228
Package: CASE [2 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 Date2018-08-15
Device Publish Date2018-05-30

On-Brand Devices [Temp Probe]

10803622140225Temp Probe
00803622133145Temp Probe

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