Plastic Mouthpieces (100)

GUDID 10857175006071

Plastic Mouthpieces box of 100

VECTRACOR INC

Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use
Primary Device ID10857175006071
NIH Device Record Keye556ba64-5260-459c-bb5b-3acf437bd993
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlastic Mouthpieces (100)
Version Model NumberZ-5000-2608
Company DUNS828416359
Company NameVECTRACOR INC
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857175006074 [Unit of Use]
GS110857175006071 [Primary]
GS120857175006078 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Product Code

BYPMouthpiece, Breathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-23
Device Publish Date2016-09-26

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00857175006012 - Vectraplex CMS2018-07-06 Vectraplex Central Monitoring System
00857175006029 - VectraplexECG System2018-07-06 VectraplexECG System with Cardio Electrical Bio-marker (CEB)
00857175006043 - Universal ECG2018-07-06 ECG Amplifier
00857175006050 - Orbit Spirometer2018-07-06 Orbit Spirometer

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