Andnesfit Health

GUDID 04897100310025

Wireless Pulse Oximeter

ANDESFIT LIMITED

Pulse oximeter, battery-powered
Primary Device ID04897100310025
NIH Device Record Key19d3857f-b915-481e-850a-f2af59532bd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAndnesfit Health
Version Model NumberADF-B06
Company DUNS664101036
Company NameANDESFIT 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 Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS104897100310025 [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 Date2021-05-11
Device Publish Date2021-05-03

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