Identity
- Trade Name
- Bloom FDA UDI
- Generic Name
- External pacemaker, epicardial pacing FDA UDI
- Model / Reference
- 206276G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863019000306 FDA UDI
- 510(k) Number
- K991293 FDA UDI
- FDA Product Code
- JOQ FDA UDI
- GMDN Term
- External pacemaker, epicardial pacing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1750 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: External pacemaker, epicardial pacing
Bloom by Fischer Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External pacemaker, epicardial pacing.
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- Osypka Medical — Osypka Medical, Inc. · Class II
- Solo Pace Control System — SOLO PACE INC · Class II
- PACE 203H — Oscor Inc. · Class II
- STREAMLINE™ — MEDTRONIC, INC. · Class II
- CARDIOTRONIC — Osypka Medical, Inc. · Class II
Cleared under the same submission
K991293 also covers:
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
- Fischer Medical
Sources (1)
- FDA UDI 5426bcab-7035-4761-b5cd-c6ce4905b0fa 33 fields · synced May 30, 2026