CAPIOX®FX
GUDID 04987350781772
FX05
TERUMO CORPORATION
Extracorporeal membrane oxygenator| Primary Device ID | 04987350781772 |
| NIH Device Record Key | b8c7be3b-a8c7-42df-8527-8bd59938eb02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAPIOX®FX |
| Version Model Number | CX*FX05RW |
| 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 |
| cvscustomerservice@terumomedical.com |
Device Dimensions
| Area/Surface Area | 0.5 Square meter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| 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 | 04987350781772 [Primary] |
FDA Product Code
| DTZ | Oxygenator, Cardiopulmonary Bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2015-09-15 |
On-Brand Devices [CAPIOX®FX]
| 04987350781772 | FX05 |
| 04987350781758 | FX05 |
| 04987350781734 | FX05 |
| 04987350781710 | FX05 |
| 04987350701206 | FX15 |
| 04987350701183 | FX15 |
| 04987350701169 | FX15 |
| 04987350701145 | FX15 |
| 04987350701121 | FX15 |
| 04987350701107 | FX15 |
| 04987350701084 | FX25 |
| 04987350701060 | FX25 |
| 04987350701046 | FX25 |
| 04987350701022 | FX25 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.