Identity
- Trade Name
- 9Line FDA UDI
- Generic Name
- Pacemaker site protection skin-adherent pad FDA UDI
- Device Name
- Disposable CardiPatch, skin patch over pacemaker site cushion (1 Case of 6 boxes. Each box contains 2 patches) FDA UDI
- Model / Reference
- R-92922 FDA UDI
- Description
- Disposable CardiPatch, skin patch over pacemaker site cushion (1 Case of 6 boxes. Each box contains 2 patches) FDA UDI
Identifiers
- Catalog Number
- R-92922 FDA UDI
- Primary DI / UDI-DI
- G096R929220 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Pacemaker site protection skin-adherent pad FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6450 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
9Line by Rising Eagle Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Rising Eagle Medical
Sources (1)
- FDA UDI ba97cd53-7634-4f97-abae-79112f29c4c3 35 fields · synced Jun 6, 2026