Pulse Oximeter

GUDID 06938368100411

General Meditech. Inc.

Pulse oximeter
Primary Device ID06938368100411
NIH Device Record Key5864cc4f-2dd9-4f7b-8ceb-72f0b594c1b2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse Oximeter
Version Model NumberG1B
Company DUNS545261786
Company NameGeneral Meditech. 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
GS106938368100411 [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 Date2024-09-04
Device Publish Date2024-08-27

On-Brand Devices [Pulse Oximeter]

06938368100411G1B
06938368113022G1B Plus

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