Philips ECG Lead

GUDID 10816317024120

Philips - AAMI 5 Lead Set M1668A, M1663A and M1949A

RENU MEDICAL, INC

Electrocardiographic lead set, reprocessed
Primary Device ID10816317024120
NIH Device Record Keycf2122a6-c6c8-49b7-a3fc-9678f06932c4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhilips ECG Lead
Version Model NumberRM-989803173131
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
GS100816317024123 [Primary]
GS110816317024120 [Package]
Contains: 00816317024123
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 Date2023-09-21
Device Publish Date2023-09-13

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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