FDA.reportPublic FDA data

Midas Rex MR8

Primary DI
00643169912205
Brand
Midas Rex MR8
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
CA875
Device description
CASE CA875 MR8 INSTRUMENT 3/4 DIN NAVIG
Published
2019-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMZINCUBATOR, NEONATAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMZIncubator, NeonatalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183644000Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions2019-05-22OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169912205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169912205006431699122056431699122050643169912205

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
098308849
Device count
1
Lot or batch
true
Sterilization required before use
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
04048675641308Babyleo TN500Drägerwerk AG & Co. KGaAFMZ2026-03-23
10889483577363AirLife™AirLife Finland OyFMZ2025-03-26
10889483577370AirLife™AirLife Finland OyFMZ2025-03-26
20889483577360AirLife™AirLife Finland OyFMZ2025-03-26
20889483577377AirLife™AirLife Finland OyFMZ2025-03-26
10889483577387AirLife™AirLife Finland OyFMZ2025-03-26
B510A31860ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
B510A31861ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
B510A4051ADVANCED INFANT WARMERADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
04942962610858V-2200 Infant Incubator ATOM MEDICAL CORPORATIONFMZ2024-10-29
04942962616102Neo-Servo i Atom Infant Incubator Model 102ATOM MEDICAL CORPORATIONFMZ2024-10-29
04942962674065V-2100G Advanced Infant Incubator ATOM MEDICAL CORPORATIONFMZ2024-10-29
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMZ2024-03-09
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMZ2022-02-08
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATUREDatex-Ohmeda, Inc.FMZ2021-11-10
00763000374716Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
00763000374723Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
10190752179608AirlifeAirLife Finland OyFMZ2021-02-26
10190752179615AirlifeAirLife Finland OyFMZ2021-02-26
20190752179605AirlifeVYAIRE MEDICAL, INC.FMZ2021-02-26
70190752179617AirlifeVYAIRE MEDICAL, INC.FMZ2021-02-26
10190752179622AirlifeAirLife Finland OyFMZ2021-02-26
10190752106130Multi-Link™AirLife Finland OyFMZ2021-01-13
10190752106147Multi-Link™AirLife Finland OyFMZ2021-01-13
20190752106137Multi-Link™Vyaire Medical OyFMZ2021-01-13
20190752106144Multi-Link™Vyaire Medical OyFMZ2021-01-13
10190752106161Multi-Link™AirLife Finland OyFMZ2021-01-13
00643169912199Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2019-06-08
00643169912182Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2019-06-01