989803134771

GUDID 10884838009452

Philips Medical Systems Hsg

Electrode skin abrasion pad

• Primary Device ID: 10884838009452
• NIH Device Record Key: ef425c6f-bfa2-46b4-ad98-916662ef474c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803134771
• Catalog Number: 989803134771
• Company DUNS: 790605856
• Company Name: Philips Medical Systems Hsg
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10884838009452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080106

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: 2021-11-24
• Device Publish Date: 2017-07-31

Devices Manufactured by Philips Medical Systems Hsg

• 00884838094826 - Cardiac Workstation: 2025-02-03 Cardiac Workstation 5000
• 00884838094833 - Cardiac Workstation: 2025-02-03 Cardiac Workstation 7000
• 00884838127692 - Paper: 2025-01-13 Thermal paper for PageWriter, 8.5" x 11"sheet. Case of 1600 sheets (8 z-foldpads of 200 sheets ea). Red grid w/2.9" (7.3cm) head
• 00884838127708 - Paper: 2025-01-13 Thermal Paper for PageWriter, A4 size z-fold. Red grid w/6.7cm header. For PageWriter 200/i, 100 & XL cardiographs
• 20884838116447 - Paper: 2025-01-13 8.5"x11" Z-fold paper, no header Cardiograph thermal paper. Red Grid. 8.5x11" (216 mm x 279 mm). Pkg = 1 case = 8 packs = 1600 s
• 20884838116430 - Paper: 2024-12-26 Thermal Array Paper Chemical/thermal paper, 10 rolls/box, roll length = 98 ft. (29.9m), width = 1.97 in (50mm), weight = 2 lbs (
• 00884838009486 - Paper: 2024-12-19 Thermal Array Paper Chemical/thermal paper, 10 rolls/box, roll length = 98 ft. (29.9m), width = 1.97 in (50mm), weight = 2 lbs (
• 00884838123717 - Care Assist: 2024-12-05 Care Assist