HANDI+

GUDID 00817770020691

Oxygen Anlayzer

MAXTEC, LLC

Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered
Primary Device ID00817770020691
NIH Device Record Key51c1703a-8ec8-41fe-82cf-e14f0fb8208c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANDI+
Version Model NumberR218P12
Company DUNS169911828
Company NameMAXTEC, LLC
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 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
GS100817770020691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-14
Device Publish Date2016-09-26

On-Brand Devices [HANDI+]

00817770020868Oxygen Analyzer with Flow Adapter
00817770020707ANALYZER, HANDI+ INTERNATIONAL
00817770020691Oxygen Anlayzer

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