MEDALink M-A0006D05-002

GUDID G096MA0006D050020

5 Lead, Pinch, Disposable/SPU, Spacelabs & Philips Compatible, 50in, ECG Leadwire, AHA/AAMI, 25/BX

Rising Eagle Medical LLC

Electrocardiographic lead set, single-use

• Primary Device ID: G096MA0006D050020
• NIH Device Record Key: f18e66dc-cc77-42ed-aab3-3a76073aa0b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDALink
• Version Model Number: M-A0006D05-002
• Catalog Number: M-A0006D05-002
• Company DUNS: 080145608
• Company Name: Rising Eagle Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G096MA0006D050020 [Primary]
HIBCC	G096MA0006D050025 [Package]; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170536

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2023-05-08
• Device Publish Date: 2023-04-28

On-Brand Devices [MEDALink]

• G096MA0002D035: GE compatible Disposable ECG Leadwire, 3-lead, Clip,AHA, 25 per box
• G096MACO170010: Philips Reusable MX 40 ECG Telemetry Leadwire Compatible Adapter
• G096MA5085EK2PH0010: Philips Reusable Compatible ECG Trunk Cable 5 Lead
• G096MA0816C030040: Philips Reusable Compatible SpO2 Adapter Cable 8pin to 9pin extension cable 12 inches
• G096MA0816C030030: Philips Reusable Compatible SpO2 Adapter Cable 8pin to 9pin extension cable 6 inches
• G096MA0002D050025: GE compatible Disposable ECG Leadwire, 5-lead, Clip, V-Lead, AHA, 25 per box
• G096MA0002D055: GE compatible Disposable ECG Leadwire, 5-lead, Clip,AHA, 25 per box
• G096MMX4060: Reusable Philips MX 40 Compatible Adapter with 6inch SPO2 Extension and Tether (1EA)
• G096MMX40120: Reusable Philips MX 40 Compatible Adapter with 12inch SPO2 Extension and Tether (1EA)
• G096MA0006D050020: 5 Lead, Pinch, Disposable/SPU, Spacelabs & Philips Compatible, 50in, ECG Leadwire, AHA/AAMI, 25/
• G096MA0001D065: 6 Lead, Pinch, Disposable/SPU, Nihon Kohden Compatible, 50in, ECG Leadwire, AHA/AAMI, 25/BX
• G096MA0001D035: 3 Lead, Pinch, Disposable/SPU, Nihon Kohden Compatible, 50in, ECG Leadwire, AHA/AAMI, 25/BX
• G096MSLARIA0: Reusable Spacelabs Aria Tele compatible adapter with ECG
• G096MSL5T100: 5 Lead, Spacelabs Reusable Compatible ECG Trunk Cable, 3M/9.8ft (1EA)
• G096MPS5VPS0505: 5V Lead, Pinch, Disposable/SPU, Spacelabs & Philips Compatible, 50in, ECG Leadwire, AHA/AAMI, 50
• G096MPS5PS0505: 5 Lead, Pinch, Disposable/SPU, Spacelabs & Philips Compatible, 50in, ECG Leadwire, AHA/AAMI, 50/
• G096MPS3PS0505: 3 Lead, Pinch, Disposable/SPU, Spacelabs & Philips Compatible, 50in, ECG Leadwire, AHA/AAMI, 50/
• G096MPHS2T60: Reusable 8pin to 9pin Philips Compatible SPO2 extension/adapter cable 6 inches (1EA)
• G096MPHS2T120: Reusable 8pin to 9pin Philips Compatible SPO2 extension/adapter cable 12 inches (1EA)
• G096MPHMX400: Reusable Philips MX 40 compatible adapter with ECG and SPO2 (1EA)
• G096MPH5T100: 5 Lead, Philips Reusable Compatible ECG Trunk Cable, 3M/9.8ft (1EA)
• G096MNK6PS0505: 6 Lead, Pinch, Disposable/SPU, Nihon Kohden Compatible, 50in, ECG Leadwire, AHA/AAMI, 50/BX
• G096MNK3PS0505: 3 Lead, Pinch, Disposable/SPU, Nihon Kohden Compatible, 50in, ECG Leadwire, AHA/AAMI, 50/BX
• G096MGE5VPS0505: 5V Lead, Pinch, Disposable/SPU, GE Compatible, 50in, ECG Leadwire, AHA/AAMI, 50/BX
• G096MGE5PS0505: 5 Lead, Pinch, Disposable/SPU, GE Compatible, 50in, ECG Leadwire, AHA/AAMI, 50/BX
• G096MGE3PS0505: 3 Lead, Pinch, Disposable/SPU, GE Compatible, 50in, ECG Leadwire, AHA/AAMI, 50/BX
• G096MNK6T100: 5 Lead, Nihon Kohden Reusable Compatible ECG Trunk Cable, 3M/9.8ft (1EA)
• G096MGE5T100: 5 Lead, GE Healthcare Reusable Compatible ECG Trunk Cable, 3M/9.8ft (1EA)
• G096MDR5PHE80: Reusable Draeger to Philips ECG Cable, 5 lead, 6 pin connector, 8.2 ft (1 ea)
• G096MNKS2SNEO5: Nihon Kohden Compatible Disposable SpO2 Sensor, Neonatal/ Adult, 50pcs/box
• G096MNKS2SADT5: Nihon Kohden Compatible Disposable SpO2 Sensor, Adult, 50pcs/box
• G096MSL10T100: 10 Lead, Spacelabs Reusable Compatible ECG Trunk Cable, 3M/9.8ft (1EA)
• G096MPH10T100: 10 Lead, Philips Reusable Compatible ECG Trunk Cable, 3M/9.8ft (1EA)
• G096MPS5PR0500: 5 Lead, Pinch, Reusable, SL & Philips Compatible, 50in, ECG Leadwire, (1EA)
• G096MPS3PR0500: 3 Lead, Pinch, Reusable, SL & Philips Compatible, 50in, ECG Leadwire, (1EA)
• G096MPS3SR0500: 3 Lead, Snap, Reusable, SL & Philips Compatible, 50in, ECG Leadwire, (1EA)
• G096MPH6T100: 6 Lead, Philips Reusable Compatible ECG Trunk Cable, 3M/9.8ft (1EA)
• G096MPH3T100: 3 Lead, Philips Reusable Compatible ECG Trunk Cable, 3M/9.8ft (1EA)
• G096MMXEP5SR0360: 5 Lead, Snap, Reusable, Philips MX40 Compatible, 36in, ECG Leadwire with Spo2 Port, (1EA)
• G096MMXEP5PR0360: 5 Lead, Pinch, Reusable, Philips MX40 Compatible, 36in, ECG Leadwire with Spo2 Port, (1EA)
• G096MMXE5SR0360: 5 Lead, Snap, Reusable, Philips MX40 Compatible, 36in, ECG Leadwire, (1EA)
• G096MMXE5PS0360: 5 Lead, Pinch, Disp/SPU, Philips MX40 Compatible, 36in, ECG Leadwire, 50/BX
• G096MMXE5PR0360: 5 Lead, Pinch, Reusable, Philips MX40 Compatible, 36in, ECG Leadwire, (1EA)
• G096MPS5PSC0505: 5 Lead, Pinch, Disp/SPU, SL & Philips Compatible, 50in, ECG Leadwire with Protective Cover, 50/B
• G096MNKTL10PR110: 10 Lead, Pinch, Reusable, Nihon Kohden Compatible, 11 ft, ECG Leadwire and Trunk Cable Combined,
• G096MNK3PR0500: 3 Lead, Pinch, Reusable, Nihon Kohden Compatible, 50in, ECG Leadwire, (1EA)
• G096MPT3SR0360: 3 Lead, Snap, Reusable, Philips Twin Pin Compatible, 36in, ECG Leadwire, 1EA
• G096MPT3PR0500: 3 Lead, Pinch, Reusable, Philips Twin Pin Compatible, 50in, ECG Leadwire, (1EA)
• G096MPT3PR0360: 3 Lead, Pinch, Reusable, Philips Twin Pin Compatible, 36in, ECG Leadwire, (1EA)
• G096MPS5SR0500: 5 Lead, Snap, Reusable, SL & Philips Compatible, 50in, ECG Leadwire, (1EA)