VERMED 4011010C

GUDID 35060441915383

Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring, with direct connection to cables and defibrillators

NISSHA MEDICAL TECHNOLOGIES LTD

External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use

• Primary Device ID: 35060441915383
• NIH Device Record Key: 89e027c9-17d0-4d24-8cff-b3f37b582dc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERMED
• Version Model Number: F7952P
• Catalog Number: 4011010C
• Company DUNS: 671405566
• Company Name: NISSHA MEDICAL TECHNOLOGIES LTD
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060441915389 [Primary]
GS1	35060441915383 [Package]; Contains: 15060441915389; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103783

FDA Product Code

• LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)

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: 2020-05-01
• Device Publish Date: 2018-01-08

On-Brand Devices [VERMED]

• 35060441915635: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915628: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915611: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915604: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915598: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915581: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915574: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915567: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915550: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915543: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915536: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915529: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 15060441915518: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915505: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915499: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915482: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915475: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915468: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915451: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915444: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915420: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915413: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915406: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915390: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915383: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
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• 35060441915369: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915352: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915345: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915338: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915321: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915314: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915307: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915291: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915284: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915277: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915260: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915253: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915246: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915239: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915222: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915215: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915208: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915192: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915185: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915178: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou
• 35060441915109: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneou