FDA.reportPublic FDA data

Covidien ECG Leads

Primary DI
10816317020580
Brand
Covidien ECG Leads
Company
RENU MEDICAL, INC
Model
RM-33110
Device description
Covidien - DL Disp. 10 Lead Cable and Lead Wire Sy
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IKDCable, Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10816317020580PackageGS110In Commercial Distribution
00816317020583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631702058010816317020580
00816317020583008163170205838163170205830816317020583

GMDN Terms

TermDefinition
Electrocardiographic lead set, reprocessedA 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 previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method

Regulatory Flags

DUNS number
100439103
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10816317024113Stryker TourniquetRM-5921-030-1352023-08-22
10816317024106Pulse Oximeter ProbeRM-23282023-08-21
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