N/A 2009101-003

GUDID 50885403252523

Resting ECG Electrodes for 12-lead

Carefusion Finland 320 Oy

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use

• Primary Device ID: 50885403252523
• NIH Device Record Key: 09f50453-0c33-419d-9af8-c249a0cdeef7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 2009101-003
• Catalog Number: 2009101-003
• Company DUNS: 367919120
• Company Name: Carefusion Finland 320 Oy
• Device Count: 100
• 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: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefu
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefu

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403252525 [Unit of Use]
GS1	50885403252523 [Package]; Contains: 70885403252527; Package: Case [10 Units]; In Commercial Distribution
GS1	70885403252527 [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: 2016-09-22

On-Brand Devices [N/A]

• 50885403287044: ECG Electrodes, 55mm Round, Clear Tape, Hydrogel
• 50885403253834: ECG Electrodes, 55mm Round, Foam, Hydrogel
• 50885403253827: ECG Electrodes, 55mm Round, Clear Tape, Hydrogel
• 50885403253810: ECG Electrodes, 55mm Round, Clear Tape, Hydrogel
• 50885403253117: ECG Electrodes, 55mm Round, Foam, Hydrogel
• 50885403252608: ECG Electrodes, 55mm Round, Cloth, Hydrogel
• 50885403252592: ECG Electrodes, 43mm Round, Foam, Hydrogel
• 50885403252585: ECG Electrodes, 55mm Round, Foam, Wet Gel
• 50885403252578: ECG Electrodes, 43mm Round, Foam, Radiolucent, Hydrogel
• 50885403252554: ECG Electrodes, 32mm Neonatal Round, Cloth, Radiolucent, Hydrogel
• 50885403252547: Resting ECG Electrodes for 12-lead, Small
• 50885403252530: Resting ECG Electrodes for 12-lead, Extra Adhesive
• 50885403252523: Resting ECG Electrodes for 12-lead
• 50885403251823: ECG Electrodes, 43mm Round, Cloth, Hydrogel
• 50885403251816: ECG Electrodes, 55mm Round, Foam, Hydrogel
• 50885403251809: ECG Electrodes, Neonatal, Radiolucent, pre-wired with DIN 3-lead set, AHA
• 70885403253807: Resting ECG Electrodes for 15-lead, Extra Adhesive
• 20885403252201: Leg Attachment Pad for Corometrics™ Fetal Scalp Electrode Cable