GS27

GUDID 00867972000250

GS27 Pre-gelled Disposable sEMG Electrodes

BIO-MEDICAL INSTRUMENTS, INC.

Electrocardiographic electrode, single-use

• Primary Device ID: 00867972000250
• NIH Device Record Key: bcd6ddaf-2c6d-4283-8eea-f3f4edea6365
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GS27
• Version Model Number: BMI GS27
• Company DUNS: 020090098
• Company Name: BIO-MEDICAL INSTRUMENTS, INC.
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867972000250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101576

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: 2016-11-30