FDA.reportPublic FDA data

MIDAS, REM, 50%-W-N2O, EAVS

Primary DI
00816711024781
Brand
MIDAS, REM, 50%-W-N2O, EAVS
Company
PARKER-HANNIFIN CORPORATION
Model
6160-EAVS
Catalog number
6160-EAVS
Device description
Midas Flowmeter, Remote, 50% Max, N2O Control+ eAVS
Published
2024-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241465000Midas Flowmeter; eAVSParker Hannifin Corporation2024-09-19BZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816711024781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816711024781008167110247818167110247810816711024781

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air/nitrous oxide breathing gas mixerAn independent mechanical device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing. The mixer receives all three gases from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. It usually delivers the gases with adjustable N2O or air concentrations and ensures a minimum O2 level to the patient through a face mask, mouthpiece, or endotracheal (ET) tube. It is used to improve O2 uptake and/or relieve pain throughout a hospital, during dental procedures, or in obstetrics during labour. It may also be attached to ventilators or anaesthesia machines.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004175550
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816711024972MATRX SCAV(WO/HOOD)WO/SHUTOFF91515197915151972026-02-23
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM40151601 KOR2025-09-24
00816711020424NITRONOX SCAVENGERNOX-53002025-09-24
00816711024958PORTER,MED BR CIR,6FT,20PCKDMC-12-6DMC-12-62025-09-17
00816711024965PORTER,MED BR CIR,10FT,20PCKDMC-12-10DMC-12-102025-09-17
00816711024941HOSE N2O DISS/DISS 8 FT850885082025-02-27
00816711024224SCAVENGER, EAVS, MIDASEAVS-5000EAVS-50002025-02-21
00816711024927DEMAND VALVE, POS PR., DISS1506-1D1506-1D2025-02-21
00816711024934HA,O2,INTL (DISSF X DISSF)2FT92305297-2 92305297-2 2025-02-21
00816711024439DIGITAL MDM ASSY-120V(STAND MT40151602 915251152024-04-05
00816711023821Digital MDM, 30% Std ISO40151602 915251762023-09-05
00816711023838DIGITAL MDM 30% GERMANY91525178915251782023-09-05
00816711023845INTL DMDM (STAND)-SPAIN91525179915251792023-09-05
00816711023852INTL DMDM 40% STAND-SWEDEN91525180915251802023-09-05
00816711023869INTL DMDM (STAND)-ISRAEL91525182915251822023-09-05
00816711023876INTL DMDM,STANDARD-AUSTRALIA91525184915251842023-09-05
00816711023883INTL DMDM (STAND)-DUTCH91525185915251852023-09-05
00816711023890INTL DMDM (STAND)-CANADA91525186915251862023-09-05
00816711023906INTL DMDM,CABINET MOUNT91525187915251872023-09-05
00816711023913INTL DMDM 30%(STAND)-ITALY91525262915252622023-09-05

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