ER920 Rozinn https://gudid.fda.gov/gudid/app/admin/udi/recordDe

GUDID B146ER9R0

ENHANCED ALGORITHM ECG EVENT RECORDER

BRAEMAR MANUFACTURING, LLC

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system

• Primary Device ID: B146ER9R0
• NIH Device Record Key: 88b7b224-53df-4c1c-808b-336221941bf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ER920 Rozinn
• Version Model Number: 900-0557-06
• Catalog Number: https://gudid.fda.gov/gudid/app/admin/udi/recordDe
• 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	B146ER9R0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071011

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: 2018-07-06
• Device Publish Date: 2017-02-11

Devices Manufactured by BRAEMAR MANUFACTURING, LLC

• B146C6M20 - C6 Monitor UGW: 2023-12-14
• B146EP2510 - ePatch 2.5, BTH: 2023-12-13
• B146EP2520 - ePatch 2.5, BTI: 2023-11-30
• B146C6M60 - C6 Monitor A10e, Sprint: 2023-06-23
• B146C6M80 - C6 Monitor A13, T Mobile: 2023-06-23
• B146C6M90 - C6 Monitor A13, Verizon: 2023-06-23
• B146EP2R10 - ePatch 2.0 rebuilt: 2022-07-21
• B146EPE1 - ePatch Electrode-patch: 2022-04-08