Philips ECG Lead

GUDID 10816317024137

Philips - 5 Lead Set, Disposable, Chest, AAMI

RENU MEDICAL, INC

Electrocardiographic lead set, reprocessed
Primary Device ID10816317024137
NIH Device Record Key900cc471-8a1f-4e64-a9db-236071198ea0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhilips ECG Lead
Version Model NumberRM-989803192141
Company DUNS100439103
Company NameRENU MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816317024130 [Primary]
GS110816317024137 [Package]
Contains: 00816317024130
Package: Case [20 Units]
In Commercial Distribution

FDA Product Code

IKDCable, Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

On-Brand Devices [Philips ECG Lead]

10816317024120Philips - AAMI 5 Lead Set M1668A, M1663A and M1949A
10816317024137Philips - 5 Lead Set, Disposable, Chest, AAMI

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