FDA.reportPublic FDA data

MIDAS REX

Primary DI
00763000521837
Brand
MIDAS REX
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
PA200
Device description
ACCY PA200 MIDAS REX REGULATOR DISS
Published
2021-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXHGAUGE, GAS PRESSURE, CYLINDER/PIPELINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXHGauge, Gas Pressure, Cylinder/PipelineAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183515000MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions2019-05-12HBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000521837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000521837007630005218377630005218370763000521837

GMDN Terms#

Term, Definition table
TermDefinition
Surgical air pipeline regulatorA reduction valve designed to lower high and variable gas pressure in a pipeline intended for surgical applications (e.g., to drive surgical power tools) to a lower and constant working pressure, typically 3 - 12 bar. It consists of a housing containing a single- or dual-stage regulator used to regulate the surgical air, connectors (these may be permanent or quick connectors), and a pressure gauge; it may include an integral filter to remove possible contaminants, sometimes with a glass bowl for the collection of oil deposits and for observation. It is typically made of metal and synthetic polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
098308849
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000374976Midas Rex LegendPC7102020-10-02
00763000244859MIDAS REXPC710-R2019-07-19
00763000080174MIDAS REXPC7102019-06-08
00763000514006MIDAS REX MR8MR8-SP14MH302022-04-22
00199150001989MR8MR8-15MH20L2026-03-09
00763000545116MIDAS REX MR8IRD8502022-06-02
00763000545123MIDAS REX MR8IRD8702022-06-02
00763000487126MIDS REX MR8MR8-10BA30D2022-01-01
00763000753412ENT MR81847B20SDM2022-12-29
00763000514020MIDAS REX CURVED BURMR8-SP14MH30T2022-04-22
00763000753382ENT MR81847B20SCT2022-12-29
20763000545134ENT MR8IRD8752022-06-02
00763000030636N/A24106 A2020-04-19
00763000031107N/A22101 A2020-04-19
00643169497542NA24106 A2015-07-07
00643169579385NA22101 A2015-06-24
00613994908308NA24106 A2015-06-16
00613994908674NA22101 A2015-06-17
00763000521622MIDAS REX MR8MR8-ASDS01-R2025-08-10
20763000545103MIDAS REX MR8IRD8002022-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813830027099Nitrogen Add On KitACCUTRON, INC.BXH2023-10-05
00813830027372FRU, Accuvalve AssemblyACCUTRON, INC.BXH2023-10-05
00813830028843FRU, Display Assy Digi-Flo Zone ValveACCUTRON, INC.BXH2023-10-05
00813830021721Recessed QC Outlet VacuumACCUTRON, INC.BXH2023-09-22
00813830021844Surface Q/C Triple OutletACCUTRON, INC.BXH2023-09-22
00813830022032Surface Q/C Dual OutletACCUTRON, INC.BXH2023-09-22
00813830022049Surface Q/C O2 OutletACCUTRON, INC.BXH2023-09-22
00813830022056Surface Imperial N2 OutletACCUTRON, INC.BXH2023-09-22
00813830022063Surface Schrader N2 OutletACCUTRON, INC.BXH2023-09-22
00813830022070Surface Q/C Vacuum OutletACCUTRON, INC.BXH2023-09-22
00813830024029Riser, FRU, O2, Cylinder RoomACCUTRON, INC.BXH2023-09-22
00813830024036Riser, FRU, N2O, Cylinder RoomACCUTRON, INC.BXH2023-09-22
00813830024432Pre-Install Digi-Flo A & C Desk MountACCUTRON, INC.BXH2023-09-22
00813830024449Pre-Install Digi-Flo B & D Wall MountACCUTRON, INC.BXH2023-09-22
00813830024753Zone Valve, Digi-FloACCUTRON, INC.BXH2023-09-22
00813830025255Zone Valve Adapter Box, Digi-FloACCUTRON, INC.BXH2023-09-22
00813830026962Zone Valve Adapter Box, Digi-Flo, NCACCUTRON, INC.BXH2023-09-22
00813830027334Digi-Flo N2O & O2 Brazed RisersACCUTRON, INC.BXH2023-09-22
00813830024791Digi-Flo Pkg. D, w Security Wall AlarmACCUTRON, INC.BXH2023-09-21
00813830024814Digi-Flo Pkg D, w Sec. Wall Alarm -NPACCUTRON, INC.BXH2023-09-21
008138300248452nd Alarm Panel, Digi-Flo, WallACCUTRON, INC.BXH2023-09-21
008138300248522nd Alarm, Digi-Flo, Wall, w SecurityACCUTRON, INC.BXH2023-09-21
00813830024982Digi-Flo Pkg C, w Sec. Desk AlarmACCUTRON, INC.BXH2023-09-21
00813830025187Digi-Flo Pkg C, w Sec. Desk Alarm -NPACCUTRON, INC.BXH2023-09-21
00813830025309Porter Manifold Adapter KitACCUTRON, INC.BXH2023-09-21
00813830025316Belmed Manifold Adapter KitACCUTRON, INC.BXH2023-09-21
00813830025323Accutron Manifold Adapter KitACCUTRON, INC.BXH2023-09-21
00813830020168FRU, Primary Check Valve O2ACCUTRON, INC.BXH2023-09-14
00813830021677Recessed Q/C Triple OutletACCUTRON, INC.BXH2023-09-14
00813830021684Recessed Q/C Dual OutletACCUTRON, INC.BXH2023-09-14