| Primary Device ID | 00607567212145 |
| NIH Device Record Key | 7f4af9a5-4131-439a-897f-9abd1fab5416 |
| Commercial Distribution Discontinuation | 2019-10-29 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ECC Pack |
| Version Model Number | BEQ-TOP 22600 |
| Catalog Number | 701051791R01 |
| 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 | |
| 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 | 00607567212145 [Primary] |
| DWE | Tubing, Pump, Cardiopulmonary Bypass |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
[00607567212145]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-29 |
| Device Publish Date | 2018-05-09 |
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| 00607567204485 | Gas Filter |
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| 00607567203419 | BEQ-RF32 |
| 00607567203358 | BEQ-HMOD 70000-USA Adult Quadrox iD, BO-VHK 71000 Venous Reservoir, BEQ-RF32 RotaFlow, Gas Filte |
| 00607567202917 | BEQ-HMOD 70000-USA Adult Quadrox iD FlowProbe Connector |
| 00607567213333 | BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, BC 60 plus, BMU Cell Ven |