Advantage Medical Cable ECG Leads

GUDID 10816317024090

AMC - Disp. 5 Lead Grouped Set Pinch (Grabber)

RENU MEDICAL, INC

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Primary Device ID10816317024090
NIH Device Record Key9b166dbd-74c9-4a46-bc30-90f7789c252b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvantage Medical Cable ECG Leads
Version Model NumberRM-LWM-341DS50/5A
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816317024093 [Primary]
GS110816317024090 [Package]
Contains: 00816317024093
Package: Case [25 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 Date2023-07-07
Device Publish Date2023-06-29

On-Brand Devices [Advantage Medical Cable ECG Leads]

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10861317023222AMC - Disp. 3 Lead DIN to Snap Leadset
10861317020689AMC - Disp. 5 Lead Grouped Set Pinch to Telepack
10861317020672AMC - Disp. 5 Lead DIN to Pinch Telemetry
10861317020665AMC - Disp. 5 Lead DIN to Pinch Leadset
10861317020658AMC- Disp. Pinch 3 Lead
10816317023376AMC - Disp. 6 Lead Grouped Set, Pinch to Molded Nihon Kohden
10816317023369AMC – Disp. 5 Lead Disposable Philips MX-40 Compatible Leadset
10816317023222AMC - Disp. 3 Lead DIN to Snap Leadset
10816317020689AMC - Disp. 5 Lead Grouped Set Pinch to Telepack
10816317020672AMC - Disp. 5 Lead DIN to Pinch Telemetry
10816317020665AMC - Disp. 5 Lead DIN to Pinch Leadset
10816317020658AMC- Disp. Pinch 3 Lead
10816317024052RM-LWM-309DS120/5AT
10816317024090AMC - Disp. 5 Lead Grouped Set Pinch (Grabber)
10816317024083AMC - Disp. 6 Lead Grouped Set
10816317024076AMC - Disp. 3 Lead DIN to Pinch Leadset
10816317024069AMC - Disp. 5 Lead DIN to Pinch Leadset
10816317024144AMC - 5 Lead Disposable DIN to Pinch, Shld, 120", OM Combiner, AHA, SS
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