Identity
- Trade Name
- Paragon Adult Maxi PMP Oxygenator FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Device Name
- The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. FDA UDI
- Model / Reference
- XCMOP405PMP FDA UDI
- Description
- The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. FDA UDI
Identifiers
- Catalog Number
- XCMOP405PMP FDA UDI
- Primary DI / UDI-DI
- 05060491617915 FDA UDI
- 510(k) Number
- K191246 FDA UDI
- FDA Product Code
- DTZ FDA UDI
- GMDN Term
- Extracorporeal membrane oxygenator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4350 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 300 Milliliter FDA UDI
Category: Extracorporeal membrane oxygenator
Paragon Adult Maxi PMP Oxygenator by Chalice Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal membrane oxygenator.
- INSPIRE — SORIN GROUP ITALIA SRL · Class II
- Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir — Terumo Cardiovascular Systems Corporation · Class II
- AMG PMP INFANT STERILE — EUROSETS SRL · Class II
- Affinity Fusion® — MEDTRONIC, INC. · Class II
- MC3 Nautilus ECMO Oxygenator — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
- CAPIOX — Terumo Corp. · Class II
- CAPIOX®RX — Terumo Corp. · Class II
- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems Corporation · 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
- Chalice Medical Limited
Sources (1)
- FDA UDI abbb5db8-4cb1-4958-bf89-91968686b36c 38 fields · synced Jun 8, 2026