Identity
- Trade Name
- ER920 Rozinn FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- ENHANCED ALGORITHM ECG EVENT RECORDER FDA UDI
- Model / Reference
- 900-0557-06 FDA UDI
- Description
- ENHANCED ALGORITHM ECG EVENT RECORDER FDA UDI
Identifiers
- Catalog Number
- https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& FDA UDI
- Primary DI / UDI-DI
- B146ER9R0 FDA UDI
- 510(k) Number
- K071011 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiography telemetric monitoring system
ER920 Rozinn by Braemar Manufacturing, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Braemar Manufacturing, LLC
Sources (1)
- FDA UDI 88b7b224-53df-4c1c-808b-336221941bf5 35 fields · synced Jun 9, 2026