FDA.reportPublic FDA data

ezPad MRI

Primary DI
EMIP53002030
Brand
ezPad MRI
Company
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Model
large
Catalog number
5300203
Device description
MRI ECG Electrode 110mm x 110mm
Published
2018-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMIP53002031PackageHIBCC25In Commercial Distribution
EMIP53002032PackageHIBCC18In Commercial Distribution
EMIP53002030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49814592090info@mipm.com

Regulatory Flags#

DUNS number
324416379
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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04255629200980NIBP Pressure cuff 20,5 - 28,5 cmSmall Adult 20,5 - 28,5 cm51000402026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmAdult 27 - 35 cm51000412026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmLarge Adult 34 - 44 cm51000422026-06-24
04255629201017Gas Sample Line SetGas Sample Line Set54000172026-06-24
EMIP51000380NIBP Pressure cuff 9 - 15 cmInfant 9 - 15 cm51000382019-11-11
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EMIP51000400NIBP Pressure cuff 20,5 - 28,5 cmSmall Adult 20,5 - 28,5 cm51000402019-11-11
EMIP51000410NIBP Pressure cuff 27 - 35 cmAdult 27 - 35 cm51000412019-11-11
EMIP51000420NIBP Pressure cuff 34 - 44 cmLarge Adult 34 - 44 cm51000422019-11-11
EMIP54000171Gas Sample Line SetGas Sample Line Set54000172019-11-11
EMIP51000430NIBP Pressure cuff 42 - 52 cmThigh 42 - 52 cm51000432019-11-11
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