BabyMAC 402207-810

GUDID 20885403252218

Infant/Pediatric Resting ECG Electrodes for 12-lead

Carefusion Finland 320 Oy

Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode

• Primary Device ID: 20885403252218
• NIH Device Record Key: 9a4c1444-a503-454f-92b3-1e1f3a125d01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BabyMAC
• Version Model Number: 402207-810
• Catalog Number: 402207-810
• Company DUNS: 367919120
• Company Name: Carefusion Finland 320 Oy
• Device Count: 50
• DM Exempt: false
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefu
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefu

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403252211 [Unit of Use]
GS1	20885403252218 [Package]; Contains: 70885403252213; Package: Box [10 Units]; In Commercial Distribution
GS1	70885403252213 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-14

Devices Manufactured by Carefusion Finland 320 Oy

• 10885403255175 - Vital Signs: 2022-10-24 Manual Bag Tube for ADU, Reusable
• 20885403248938 - Vital Signs: 2022-08-05 CO2 B-Line and Elbow Adapter, Disposable
• 20885403248945 - Vital Signs: 2022-08-05 CO2 B-Line and Straight Adapter, Disposable
• 20885403248952 - Vital Signs: 2022-08-05 CO2 B-Line, Disposable
• 70885403249008 - Vital Signs™: 2022-08-05 Vital Signs™ Gas Sampling Line, M/F Luer, Disposable, 3m/10ft
• 20885403251037 - Vital Signs: 2022-08-05 Anesthesia B-Line and Elbow Adapter, Disposable
• 20885403251044 - Vital Signs: 2022-08-05 Anesthesia B-Line and Straight Adapter, Disposable
• 20885403251051 - Vital Signs: 2022-08-05 Anesthesia B-Line, Disposable