| Primary Device ID | 00607567213111 |
| NIH Device Record Key | 8011f98a-b215-49bf-b41d-f8902378f7c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adult ECC |
| Version Model Number | BEQ-TOP 24202 |
| Catalog Number | 701054295R02 |
| Company DUNS | 001660786 |
| Company Name | DATASCOPE CORP. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607567213111 [Primary] |
| DWE | Tubing, Pump, Cardiopulmonary Bypass |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00607567213111]
Ethylene Oxide
[00607567213111]
Ethylene Oxide
[00607567213111]
Ethylene Oxide
[00607567213111]
Ethylene Oxide
[00607567213111]
Ethylene Oxide
[00607567213111]
Ethylene Oxide
[00607567213111]
Ethylene Oxide
[00607567213111]
Ethylene Oxide
[00607567213111]
Ethylene Oxide
[00607567213111]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-23 |
| Device Publish Date | 2019-05-15 |
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| 00607567203037 | BEQ-HMOD 70000 Softshell venous reservoir 800 ml CDI Sat cell 3/8" Blood Microfilter system Preb |
| 00607567212404 | BEQ-HNOD 70000-USA Adult QuadroxiD, Softshell Venous Reserv. 800ml, Better Bladder 3/8, CDI Sat |
| 00607567213111 | BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, CDI Sai Cell 3/8" System 100 |