Vermed 32028777

GUDID 50009336008853

SET OF 3 PRE-WIRED RT ADULT ELECTRODES

GRAPHIC CONTROLS ACQUISITION CORP

Electrocardiographic electrode, single-use

• Primary Device ID: 50009336008853
• NIH Device Record Key: 61a1cdde-5e87-4474-a7cc-23112d8e0da6
• Commercial Distribution Discontinuation: 2019-06-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vermed
• Version Model Number: IP-Set M3 RT Adult-US
• Catalog Number: 32028777
• Company DUNS: 002111896
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Device Count: 1
• 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: true
• 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: 800-669-6905
• Email: info@vermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10009336008855 [Primary]
GS1	30009336008859 [Package]; Contains: 10009336008855; Package: [4 Units]; Discontinued: 2019-06-03; Not in Commercial Distribution
GS1	50009336008853 [Package]; Contains: 30009336008859; Package: [12 Units]; Discontinued: 2019-06-03; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101685

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: 4
• Public Version Date: 2019-06-04
• Device Publish Date: 2017-10-30

On-Brand Devices [Vermed]

• 10813150022269: A10091-4
• 10813150021606: VMB20900-24-3A
• 80813150021612: A10091-5
• 60813150021618: A10091-30
• 30813150021914: 7/POUCH, 100 POUCHES/CASE, 700 PER CASE
• 40813150021614: A10091-3
• 15060441915068: IP Set ECG Adapter Cable
• 15060441915044: IP Set ECG Adapter Cable
• 15060441915020: IP Set ECG Adapter Cable
• 15060441915006: IP Set ECG Adapter Cable
• 15060441914986: IP Set ECG Adapter Cable
• 15060441914962: IP Set ECG Adapter Cable
• 15060441914931: IP Set ECG Adapter Cable
• 15060441914924: IP Set ECG Adapter Cable
• 15060441914917: IP Set ECG Adapter Cable
• 15060441914900: IP Set ECG Adapter Cable
• 15060441914894: IP Set ECG Adapter Cable
• 15060441914887: IP Set ECG Adapter Cable
• 15060441914870: IP Set ECG Adapter Cable
• 15060441914863: IP Set ECG Adapter Cable
• 15060441914856: IP Set ECG Adapter Cable
• 15060441914849: IP Set ECG Adapter Cable
• 15060441914832: IP Set ECG Adapter Cable
• 15060441914825: IP Set ECG Adapter Cable
• 15060441914818: IP Set ECG Adapter Cable
• 15060441914801: IP Set ECG Adapter Cable
• 15060441914795: IP Set ECG Adapter Cable
• 15060441914788: IP Set ECG Adapter Cable
• 15060441914771: IP Set ECG Adapter Cable
• 15060441914764: IP Set ECG Adapter Cable
• 15060441914757: IP Set ECG Adapter Cable
• 15060441914740: IP Set ECG Adapter Cable
• 15060441914733: IP Set ECG Adapter Cable
• 15060441914726: IP Set ECG Adapter Cable
• 15060441914719: IP Set ECG Adapter Cable
• 15060441914702: IP Set ECG Adapter Cable
• 15060441914696: IP Set ECG Adapter Cable
• 15060441914689: IP Set ECG Adapter Cable
• 15060441914672: IP Set ECG Adapter Cable
• 15060441914665: IP Set ECG Adapter Cable
• 15060441914658: IP Set ECG Adapter Cable
• 15060441914641: IP Set ECG Adapter Cable
• 15060441914634: IP Set ECG Adapter Cable
• 15060441914627: IP Set ECG Adapter Cable
• 15060441914610: IP Set ECG Adapter Cable
• 15060441914603: IP Set ECG Adapter Cable
• 15060441914597: IP Set ECG Adapter Cable
• 15060441914580: IP Set ECG Adapter Cable
• 15060441914573: IP Set ECG Adapter Cable
• 15060441914566: IP Set ECG Adapter Cable