ER920W Patient Cable

GUDID B146ER9100

BRAEMAR MANUFACTURING, LLC

Electrocardiographic lead set, reusable

• Primary Device ID: B146ER9100
• NIH Device Record Key: df3d7c11-bdfc-43b3-9b40-7faa84178aaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ER920W Patient Cable
• Version Model Number: 350-0173-10
• Company DUNS: 049529118
• Company Name: BRAEMAR MANUFACTURING, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B146ER9100 [Primary]

FDA Product Code

• IKD: Cable, Electrode

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-21
• Device Publish Date: 2019-10-08

On-Brand Devices [ER920W Patient Cable]

• B146ER990: 350-0173-09
• B146ER9100: 350-0173-10