Pylo Health

GUDID 00860011521266

LTE connected spot measurement pulse oximeter

Prevounce Health, Inc

Pulse oximeter
Primary Device ID00860011521266
NIH Device Record Keyf123d461-8cbf-41ea-915e-d492a01bbc2e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePylo Health
Version Model NumberOX1-LTE
Company DUNS116961530
Company NamePrevounce Health, Inc
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 Batchfalse
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
GS100860011521266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-26
Device Publish Date2024-09-18

On-Brand Devices [Pylo Health]

00860004709596Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor.
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00860011521228Pylo Blood Glucose Test Strip
00860011521211Pylo Control Solution
00860011521204Pylo Blood Glucose Meter Device GL1-LTE
00860011521266LTE connected spot measurement pulse oximeter

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