| Primary Device ID | 00607567204164 |
| NIH Device Record Key | bd58ce1c-645f-407c-9a4b-929e976eb224 |
| Commercial Distribution Discontinuation | 2018-07-20 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Open Heart Pack |
| Version Model Number | BO-TOP 29403 |
| Catalog Number | 701056554 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607567204164 [Primary] |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
[00607567204164]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-28 |
| Device Publish Date | 2015-11-21 |
| 00607567208650 | BEQ-HMO 71000 Quadrox i Adult with integral filter VHK 71000 Venous Reservoir - uncoated BEQ-RF3 |
| 00607567204164 | HMO 71000 (BO Coated) Quadrox i Adult with integral filter BO-VHK 71000 Venous Reservoir BO-RF32 |
| 00607567201194 | BE-HMO 71000 VHK 71000 BEQ-RF32 BC 60 Plus BMU CEll Prebypass Filter Bacteria Filter Gas Fileter |