Primary Device ID | 04987350781758 |
NIH Device Record Key | e85591ce-cc6b-4fd7-9ec4-756797b10cee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CAPIOX®FX |
Version Model Number | CX*FX05RE |
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 |
Phone | 1-800-521-2818 |
cvscustomerservice@terumomedical.com |
Area/Surface Area | 0.5 Square meter |
Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04987350781758 [Primary] |
DTZ | Oxygenator, Cardiopulmonary Bypass |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-01-22 |
Device Publish Date | 2015-09-15 |
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 |
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 |