DL950 Braemar

GUDID B146DL95000

BRAEMAR MANUFACTURING, LLC

Electrocardiographic ambulatory recorder

• Primary Device ID: B146DL95000
• NIH Device Record Key: 1f1f5b8f-5401-4c89-9392-8f08442ff8a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DL950 Braemar
• Version Model Number: 900-0616-00
• Company DUNS: 049529118
• Company Name: BRAEMAR MANUFACTURING, LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	B146DL95000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071733

FDA Product Code

• MWJ: Electrocardiograph, Ambulatory (Without Analysis)

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: 2019-11-08
• Device Publish Date: 2018-12-13

On-Brand Devices [DL950 Braemar]

• B146DL95000: 900-0616-00
• B146DL95010: 900-0616-01