CAPIOX CX*FX05EA
GUDID 04987350739100
CAPIOX FX Oxygenator
TERUMO CORPORATION
Extracorporeal membrane oxygenator| Primary Device ID | 04987350739100 |
| NIH Device Record Key | e0578d4f-6e02-40ab-b658-f2d9827cdf93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAPIOX |
| Version Model Number | CX*FX05EA |
| Catalog Number | CX*FX05EA |
| Company DUNS | 690543319 |
| Company Name | TERUMO CORPORATION |
| 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 | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx | |
| Phone | +1(800)521-2818 |
| xxx@xx.xx |
Device Dimensions
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
| Area/Surface Area | 0.5 Square meter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987350739100 [Primary] |
FDA Product Code
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-09 |
| Device Publish Date | 2021-07-01 |
On-Brand Devices [CAPIOX]
| 04987350769213 | CAPIOX Cardiotomy Reservoir |
| 54987350706336 | CAPIOX Luer Thermistor |
| 54987350705735 | CAPIOX Bubble Trap |
| 54987350705698 | CAPIOX Bubble Trap |
| 04987350739100 | CAPIOX FX Oxygenator |
| 04987350739124 | CAPIOX FX Oxygenator |
| 04987350739087 | CAPIOX FX Oxygenator |
| 04987350739063 | CAPIOX FX Oxygenator |
| 04987350739049 | CAPIOX RX Oxygenator |
| 04987350739025 | CAPIOX RX Oxygenator |
| 54987350771839 | Device Holder |
| 54987350764053 | Device Holder |
| 54987350764039 | Device Holder |
| 54987350764015 | Device Holder |
| 54987350744598 | Device Holder |
| 04987350742575 | Device Holder |
| 54987350734650 | Device Holder |
| 54987350734636 | Device Holder |
| 54987350734612 | Device Holder |
| 54987350733677 | Device Holder |
| 54987350733653 | Device Holder |
| 54987350703762 | Device Holder |
| 54987350743256 | CAPIOX CARDIOPLEGIA |
Trademark Results [CAPIOX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPIOX 74561748 1957236 Live/Registered |
TERUMO KABUSHIKI KAISHA 1994-08-16 |
 CAPIOX 73401694 1295899 Dead/Cancelled |
Terumo Kabushiki Kaisha 1982-11-04 |
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