Ambu WhiteSensor 4535MECG Electrodes 4535M

GUDID 05060038512864

Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free For short-term monitoring Packing: 60 pouch/300 inner box/ 3000 carton

Ambu A/S

Electrocardiographic electrode, single-use

• Primary Device ID: 05060038512864
• NIH Device Record Key: d62832dc-7a92-4f2a-bc87-c03cd9fe9089
• Commercial Distribution Discontinuation: 2021-01-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ambu WhiteSensor 4535MECG Electrodes
• Version Model Number: 4535M
• Catalog Number: 4535M
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 60
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060038510549 [Package]; Contains: 05060038512857; Package: [10 Units]; Discontinued: 2021-01-31; Not in Commercial Distribution
GS1	05060038512857 [Package]; Package: [5 Units]; Discontinued: 2021-01-31; Not in Commercial Distribution
GS1	05060038512864 [Primary]
GS1	05707480129393 [Unit of Use]

FDA Product Code

• DRX: Electrode, electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-12-16
• Device Publish Date: 2016-09-26

On-Brand Devices [Ambu WhiteSensor 4535MECG Electrodes]

• 05060038512857: Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free For sh
• 05060038512864: Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free For sh