chalicemedical.comCMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
Chalice Medical , Ltd.
Chalice Medical Ltd
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013267343 | 3013267343 | Chalice Medical Ltd | 1 | N | 2026-01-01 | Manton Wood Enterprise Park Worksop Nottinghamshire GB S80 2RS |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05060491614129 | Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator - The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less. | +441909470777 | enquiries@chalicemedical.com |
| 05060491617915 | Paragon Adult Maxi PMP Oxygenator - 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. | +441909470777 | enquiries@chalicemedical.com |
| 05060491619810 | CMO8 Adult PMP Oxygenator with Tubing Pack - The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less. | +441909470777 | enquiries@chalicemedical.com |
| 05060912587483 | CMO8 Adult PMP Oxygenator with Tubing Pack - The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less. | +440190917077 | enquiries@chalicemedical.com |
| 15060491614126 | Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator - The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less. | +441909470777 | enquiries@chalicemedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 253882 | 1270328749 | K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | DTZ | 2023-11-01 |
| 253882 | 1421194498 | K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | DTZ | 2020-09-18 |
| 253882 | 1015513018 | K191246 | Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) | DTZ | 2020-02-28 |
| 253882 | 1021525556 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DTZ | 3 | 2023-11-01 |
PMN#
Paragon Adult Maxi PMP Oxygenator With Tubing Pack
Chalice Medical Ltd
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
Chalice Medical Ltd
GUDID#
CMO8 Adult PMP Oxygenator with Tubing Pack - The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
2025-02-07
CMO8 Adult PMP Oxygenator with Tubing Pack - The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
2024-10-07
CMO8 Adult PMP Oxygenator with Tubing Pack - The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
2024-10-07
Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator - The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
2023-11-07
Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator - The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
2023-11-07
Paragon Adult Maxi PMP Oxygenator - 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.
2021-01-20