BTP-1000A

GUDID B146BTPA10

BRAEMAR MANUFACTURING, LLC

Electrocardiographic ambulatory recorder

• Primary Device ID: B146BTPA10
• NIH Device Record Key: de95c16b-023a-4973-bba6-86c4d1511b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTP-1000A
• Version Model Number: 02-00143
• 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	B146BTPA10 [Primary]

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia
• IKD: Cable, Electrode

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-24
• Device Publish Date: 2020-07-16

On-Brand Devices [BTP-1000A]

• B146BTPA20: 02-01576
• B146BTPA10: 02-00143