| Primary Device ID | 00607567207523 |
| NIH Device Record Key | 02812d5b-c2e8-4a66-9a85-d2e817bab274 |
| Commercial Distribution Discontinuation | 2018-12-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SGD Pack |
| Version Model Number | BO-TOP 35503 |
| Catalog Number | 701067668 |
| 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 | 00607567207523 [Primary] |
| DWE | Tubing, Pump, Cardiopulmonary Bypass |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
[00607567207523]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-28 |
| Device Publish Date | 2017-03-31 |
| 00607567212558 | BO-HMOD 70000-USA Adult Quadrox iD, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter |
| 00607567207530 | BEQ-HMOD 70000-USA Adult Quadrox iD, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter |
| 00607567207523 | BO-HMOD 70000-USA Adult Quadrox iD, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter |