Philips

GUDID 10816317024014

ECG Cable, 5-Lead, Grabbers, Single Patient Use, 85cm

RENU MEDICAL, INC

Electrocardiographic lead set, reprocessed

• Primary Device ID: 10816317024014
• NIH Device Record Key: 0bddbba0-2315-41f2-ac96-a39d3b884102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips
• Version Model Number: RM-989803172031
• Company DUNS: 100439103
• Company Name: RENU MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816317024017 [Primary]
GS1	10816317024014 [Package]; Contains: 00816317024017; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• IKD: Cable, Electrode

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-19
• Device Publish Date: 2022-07-11

Devices Manufactured by RENU MEDICAL, INC

• 10816317024144 - Advantage Medical Cable ECG Leads: 2024-01-26 AMC - 5 Lead Disposable DIN to Pinch, Shld, 120", OM Combiner, AHA, SS
• 10816317024137 - Philips ECG Lead: 2023-11-02 Philips - 5 Lead Set, Disposable, Chest, AAMI
• 10816317024120 - Philips ECG Lead: 2023-09-21 Philips - AAMI 5 Lead Set M1668A, M1663A and M1949A
• 10816317024113 - Stryker Tourniquet: 2023-08-30 Stryker Color Cuff II Adt 30x4in. 5921-030-135
• 10816317024106 - Pulse Oximeter Probe: 2023-08-29 LNCS Infant Probe
• 10816317022522 - HoverTech Lateral Transfer Mat: 2023-07-14 HoverMatt Lateral Transfer Mattress HM39SPU
• 10816317022539 - HoverTech Lateral Transfer Mat: 2023-07-14 HoverMatt Lateral Transfer Mattress HM50SPU
• 10816317023215 - HoverTech Lateral Transfer Mat: 2023-07-14 HoverMatt Lateral Transfer Mattress HM34SPU-HLF