IMCO

GUDID 10815842021383

23x34(mm), PET+Ag/Agcl, Electrode, EKG TAB Resting

BIOPROTECH INC.

Electrocardiographic electrode, single-use

• Primary Device ID: 10815842021383
• NIH Device Record Key: 9e7d4a38-b5a9-4822-ad51-7c7f2a9b4796
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMCO
• Version Model Number: 2030-IMC
• Company DUNS: 688460539
• Company Name: BIOPROTECH 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

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815842021386 [Primary]
GS1	10815842021383 [Package]; Contains: 00815842021386; Package: Inner Box [5 Units]; In Commercial Distribution
GS1	30815842021387 [Package]; Contains: 00815842021386; Package: Carton Box [5 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-26
• Device Publish Date: 2025-05-16

Devices Manufactured by BIOPROTECH INC.

• 18809083946880 - PROPLATE: 2025-05-28 Electrosurgical Unit Grounding Pad, Return, Uncorded, Disposable
• 10815842021383 - IMCO: 2025-05-2623x34(mm), PET+Ag/Agcl, Electrode, EKG TAB Resting
• 10815842021383 - IMCO: 2025-05-26 23x34(mm), PET+Ag/Agcl, Electrode, EKG TAB Resting
• 20851255007047 - Dynamic DIAGNOSTICS, INC: 2025-03-20 Slim, Button, 2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister package
• 00851255007050 - Dynamic DIAGNOSTICS, INC: 2025-03-20 2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister, Non-sterile, 200 pcs per bulk pack
• 00851255007067 - Dynamic DIAGNOSTICS, INC: 2025-03-20 2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Non-sterile, 200 pcs per bulk pack
• 00851255007074 - Dynamic DIAGNOSTICS, INC: 2025-03-20 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, non-sterile, 200 pcs per bulk pack
• 00851255007081 - Dynamic DIAGNOSTICS, INC: 2025-03-20 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Non-sterile, 200 pcs per bulk pack
• 20851255007092 - Dynamic DIAGNOSTICS, INC: 2025-03-20 Slim, Rocker, 2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister package