ViaMed

GUDID 00811382015632

Electrode L

RECE INTERNATIONAL CORPORATION

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

• Primary Device ID: 00811382015632
• NIH Device Record Key: 9706d256-f3ca-470b-8e1f-0773657ca413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViaMed
• Version Model Number: 13210
• Company DUNS: 787828537
• Company Name: RECE INTERNATIONAL CORPORATION
• Device Count: 2000
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811382013089 [Unit of Use]
GS1	00811382015632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041954

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-18

On-Brand Devices [ViaMed]

• 00811382019661: Sharp Container 13liter Yellow
• 00811382019654: Sharp Container 7liter Yellow
• 00811382019647: Sharp Container 5liter Yellow
• 00811382019630: Sharp Container 3liter Yellow
• 00811382019623: Sharp Container 1liter Yellow
• 00811382018770: Sharp Container 13liter Red
• 00811382018756: Sharp Container 7liter Red
• 00811382015649: Electrode S
• 00811382015632: Electrode L
• 00811382013775: Sphygmomanometer and Steto
• 00811382013461: Sharp Container 5liter Red
• 00811382013454: Sharp Container 3liter Red
• 00811382013447: Sharp Container 1liter Red
• 00811382011139: Speculum S
• 00811382011122: Speculum M
• 00811382011115: Speculum L
• 00811382011085: Cervical Scraper
• 00811382010682: Sphygmomanometer Pocket
• 00811382010675: Sphygmomanometer Floor
• 00811382010668: Sphygmomanometer Desk
• 00811382010651: Electrode S
• 00811382010644: Electrode L
• 00811382013119: Sharp Container 1 Galon
• 00811382010606: Polyethylene and stainless steel. Fine gauge, tri-bevel tip for virtually painless smapling. Uni
• 00811382011474: Chest piece with two functions. The binaural head frame is made seamless brass tubes. Thick wall
• 00811382011450: Deluxe chrome palm aneroid gauge, 300mm HG gauge with stethoscope. Deluxe Calibrated nylon cuff
• 00811382010781: Deluxe chrome palm aneroid gauge, 300mm HG gauge with stethoscope. Deluxe Calibrated nylon cuff
• 00811382010767: Deluxe chrome palm aneroid gauge, 300mm HG gauge. Deluxe Calibrated nylon cuff with velcro an dd
• 00811382011542: Chest piece with two functions. The binaural head frame is made seamless brass tubes. Thick wall
• 00811382011481: High acoustical quality. Heavy-walled 22" tubing. Latex Free. Includes five-in-one accessory kit
• 00811382011726: High accuracy and fast response, easy to read digital display. Peak-hold and auto shut-off func