Identity
- Trade Name
- MYOtherm XP™ FDA UDI
- Generic Name
- Cardioplegia solution administration kit FDA UDI
- Device Name
- HEAT EXCHANGER CBXP41 MYOTHERM INC 4PK FDA UDI
- Model / Reference
- CBXP41 FDA UDI
- Description
- HEAT EXCHANGER CBXP41 MYOTHERM INC 4PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000218959 FDA UDI
- FDA Product Code
- DTR FDA UDI
- GMDN Term
- Cardioplegia solution administration kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4240 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardioplegia solution administration kit
MYOtherm XP™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardioplegia solution administration kit.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class II
- MPS 3 ND Delivery Set w/AA w/106cm (16C) — QUEST MEDICAL INC · Class II
- MPS® Low Volume Delivery Set — QUEST MEDICAL INC · Class II
- MPS 3 Additive Delivery Line — QUEST MEDICAL INC · Class II
- MPS — QUEST MEDICAL INC · Class II
- MPS 3 ND Delivery Set w/AA w/183 Line (16C) — QUEST MEDICAL INC · Class II
- Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class I
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
- Medtronic, Inc.
Sources (1)
- FDA UDI 15f08c98-2ba3-490a-aa0e-165374a4a854 35 fields · synced May 30, 2026