| Primary Device ID | 05060491617915 |
| NIH Device Record Key | abbb5db8-4cb1-4958-bf89-91968686b36c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Paragon Adult Maxi PMP Oxygenator |
| Version Model Number | XCMOP405PMP |
| Catalog Number | XCMOP405PMP |
| Company DUNS | 236289299 |
| Company Name | CHALICE MEDICAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com | |
| Phone | +441909470777 |
| enquiries@chalicemedical.com |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060491617915 [Primary] |
| GS1 | 15060491617912 [Package] Package: BOX [12 Units] In Commercial Distribution |
| DTZ | Oxygenator, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-28 |
| Device Publish Date | 2021-01-20 |
| 15060491614126 - Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator | 2023-11-15 The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulm |
| 05060491617915 - Paragon Adult Maxi PMP Oxygenator | 2021-01-28The 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. |
| 05060491617915 - Paragon Adult Maxi PMP Oxygenator | 2021-01-28 The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and |