Ambu WhiteSensor 4500M-H

Basic Information

• Brand Name: Ambu WhiteSensor 4500M-H
• Primary DI: 05707480141449
• Version / Model: 4500M-H/3
• Catalog Number: 4500M-H/3
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2019-06-03
• Public Version: 3
• Public Version Date: 2021-05-31
• Public Version Status: Update
• Public Device Record Key: 1394af33-5682-49fa-9f50-8dcd03cf52fd
• Distribution End Date: 2021-05-30

Device Description

Ambu WhiteSensor ST Monitoring Wet Gel

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRX	Electrode, electrocardiograph	Cardiovascular	870.2360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480141463	GS1		6	Not in Commercial Distribution	2021-05-30
Package	05707480141456	GS1		200	Not in Commercial Distribution	2021-05-30
Primary	05707480141449	GS1
Unit of Use	05707480141432	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius