Disposable Skin Temperature Probes

GUDID 05055931132042

FLEXICARE MEDICAL LIMITED

General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use
Primary Device ID05055931132042
NIH Device Record Keyd23dcdcb-ca9c-4cac-ac9d-16c11e9cac00
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Skin Temperature Probes
Version Model NumberNF-023U
Company DUNS504406273
Company NameFLEXICARE MEDICAL LIMITED
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS105055931132042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPLIncubator, Neonatal Transport

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-04
Device Publish Date2023-07-27

On-Brand Devices [Disposable Skin Temperature Probes]

00854401006310NF-023U
05055931132042NF-023U

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