Identity
- Trade Name
- BlueSky FDA UDI
- Generic Name
- Single-chamber implantable pacemaker, rate-responsive FDA UDI
- Device Name
- BlueSky SR Celea 1100 FDA UDI
- Model / Reference
- TPM025U FDA UDI
- Description
- BlueSky SR Celea 1100 FDA UDI
Identifiers
- Catalog Number
- TPM025U FDA UDI
- Primary DI / UDI-DI
- 08031527019024 FDA UDI
- PMA Number
- P950029 FDA UDI
- FDA Product Code
- DXY FDA UDI
- GMDN Term
- Single-chamber implantable pacemaker, rate-responsive FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.3610 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Single-chamber implantable pacemaker, rate-responsive
BlueSky by Microport Crm Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P950029 also covers:
- BlueSky — MICROPORT CRM SRL
- BlueSky — MICROPORT CRM SRL
- BlueSky — MICROPORT CRM SRL
- Esprit — MICROPORT CRM SRL
- Esprit — MICROPORT CRM SRL
- Reply — MICROPORT CRM SRL
- Reply — MICROPORT CRM SRL
- Screwdriver — MICROPORT CRM SRL
- SmartView — MICROPORT CRM SRL
- Smartview — MICROPORT CRM SRL
- Vega — MICROPORT CRM SRL
- Vega — MICROPORT CRM SRL
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microport Crm Srl
Sources (1)
- FDA UDI a971b52a-1e04-4b39-bdfd-fa369d6f1c0f 36 fields · synced Jun 8, 2026