Identity
- Trade Name
- Surge Cardiovascular FDA UDI
- Generic Name
- Cardioplegia solution administration adaptor FDA UDI
- Device Name
- Vessel Cannula, Guyton soft tip IMA needle, 1.5mm tip FDA UDI
- Model / Reference
- PER-3015S FDA UDI
- Description
- Vessel Cannula, Guyton soft tip IMA needle, 1.5mm tip FDA UDI
Identifiers
- Catalog Number
- PER-3015S FDA UDI
- Primary DI / UDI-DI
- 00817278010439 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardioplegia solution administration adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Cardioplegia solution administration adaptor
Surge Cardiovascular by Med Michigan Holdings Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardioplegia solution administration adaptor.
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- Cardioplegia solution administration adaptor — LivaNova USA, Inc. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- PERFUSION ADAPTER SET — NOVOSCI CORP. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- Cardioplegia solution administration adaptor — LivaNova USA, Inc. · Class II
- DLP® — MEDTRONIC, INC. · Class II
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
- Med Michigan Holdings Llc
Sources (1)
- FDA UDI be19f07e-1e8d-40fa-bdf1-abb3024a1e93 34 fields · synced May 30, 2026