INTEGRAL PROCESS Cables & Leadwires 70629NG

GUDID 03700506303953

CLIP LEADWIREFOR INTEGRAL PROCESS TRUNK CAB

NISSHA MEDICAL TECHNOLOGIES SAS

Electrocardiographic lead set, reusable

• Primary Device ID: 03700506303953
• NIH Device Record Key: d968305a-e5ed-4164-9f33-6fab3bf82fea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRAL PROCESS Cables & Leadwires
• Version Model Number: ECG Cable
• Catalog Number: 70629NG
• Company DUNS: 391906658
• Company Name: NISSHA MEDICAL TECHNOLOGIES SAS
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700506303953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162768

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: 2022-08-30
• Device Publish Date: 2022-08-22

On-Brand Devices [INTEGRAL PROCESS Cables & Leadwires]

• 03700506317318: CABLE ECG 10 LEAD IEC - CLIP / GLOBE® SYSTEM COMPATIBLE
• 03700506317882: Medical Device ECG Cable 10 leads for connecting GLOBE® SYSTEM monitor to Snap ECG Electrodes
• 03700506303151: SP02 EXTENSION CABLE MINDRAY COMPATIBLE
• 03700506304066: TRUNK CABLE - 10 LEADS BARD COMPATIBLE
• 03700506303953: CLIP LEADWIREFOR INTEGRAL PROCESS TRUNK CAB
• 03700506319411: SET OF 10 BANANA LEADWIRES - AAMI FOR INTEGRAL PROCESS TRUNK CABLE
• 03700506319251: TRUNK CABLE - 10 LEADS BARD COMPATIBLE
• 03700506300433: CLIP RADIOTRANSLUCENT LEADWIRE FOR INTEGRAL PROCESS TRUNK CABLE
• 03700506319459: Set of 5 Clip ECG Leadwires for Integral Process Trunk Cable - US Colour Code
• 03700506319176: Pediatric ECG Trunk Cable - 3 Leads - PHILIPS compatible - US Colour Code
• 03700506318919: ECG Trunk Cable - 3 Leads - SPACELABS compatible - US Colour Code
• 03700506318902: ECG Trunk Cable - 5 Leads - SPACELABS compatible - US Colour Code
• 03700506312924: Set of 5 Banana ECG Leadwires for Integral Process Trunk Cable - US Colour Code
• 03700506311422: Pediatric ECG Trunk Cable - 3 Leads - MARQUETTE HELLIGE compatible - US Colour Code
• 03700506304813: ECG Trunk Cable - 5 Leads - MARQUETTE HELLIGE compatible - US Colour Code
• 03700506304790: ECG Trunk Cable - 3 Leads - MARQUETTE HELLIGE compatible - US Colour Code
• 03700506304349: ECG Trunk Cable - 3 Leads - PHILIPS compatible - US Colour Code
• 03700506303809: Set of 3 Clip ECG Leadwires for Integral Process Trunk Cable - US Colour Code
• 03700506303700: Set of 5 Clip ECG Leadwires for Integral Process Trunk Cable - US Colour Code
• 03700506303625: Set of 5 Snap ECG Leadwires for Integral Process Trunk Cable - US Colour Code
• 03700506303601: Set of 3 Snap ECG Leadwires for Integral Process Trunk Cable - US Colour Code
• 03700506320196: Trunk Cable - 10 Leads - GE compatible - Length 5,5m - US Colour Code
• 03700506320189: ECG Trunk Cable - 10 Leads - BARD compatible - Length 5,5m - US Colour Code
• 03700506319466: Set of 5 Clip Leadwires for Integral Process Trunk Cable - US Colour Code
• 03700506319046: Trunk Cable - 5 Leads - Mennen compatible - Length 3,5m - US Colour Code
• 03700506304653: Trunk Cable - 5 Leads - Mennen compatible - US Colour Code
• 03700506319480: SET OF 5 CLIP LEADWIRES - AAMI FOR ORIGINAL GE MARQUETTE
• 03700506318940: TRUNK CABLE - 10 LEADS 5+5GE MARQUETTE HELLIGE COMPATIBLE