FDA.report

Single_Pat_Use_ECG_3_Lead_IEC2

Primary DI
04048675251118
Brand
Single_Pat_Use_ECG_3_Lead_IEC2
Company
Drägerwerk AG & Co. KGaA
Model
MP00877
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
IKDCable, Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048675251118PrimaryGS10
04048675421764Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675251118040486752511184048675251118
04048675421764040486754217644048675421764

GMDN Terms

TermDefinition
Electrocardiographic lead set, single-useA collection of non-sterile, noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+494518820info@draeger.com

Regulatory Flags

DUNS number
315578914
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04048675558736Filter SafeStar 55 PlusMP057902023-01-09
04048675665762Filter SafeStar 90 PlusMP057852023-01-09
04048675665786Filter SafeStar 60A PlusMP057952023-01-09
04048675665823Filter/HME TwinStar HEPA PlusMP058012023-01-09
04048675253426Mask NovaStarTS,NIV,w/SE,LMP015812015-10-24
04048675253402Mask NovaStarTS,NIV,w/SE,SMP015792015-10-24
04048675253419Mask NovaStarTS,NIV,w/SE,MMP015802015-10-24
04048675379300IBP Cable Utah26064912026-01-07
04048675557722IBP Adapter Cable Dräger 7pin26075582026-01-07
04048675379072IBP cable Becton Dickinson26064882026-01-06
04048675379089IBP Cable Abbott, Medex26064902026-01-06
04048675379096IBP cable Edwards26064892026-01-06
04048675557739IBP Adapter Cable Drager 10pin26075592026-01-06
04048675428909ThermoTrace_Peripheral_5pcsMX110012015-10-24
04048675428916ThermoTrace Core (5pcs)MX110002015-10-24

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B631DLSRPHP5L4F1SureLeadAuthentic MedicalIKD2026-03-13
B631EXTGE6PL8F1SureleadAuthentic MedicalIKD2026-03-13
B631TCGE2GE63M1SureleadAuthentic MedicalIKD2026-03-13
20885380208536CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
20885380208543CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
50885380208551CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
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