| Primary Device ID | 00607567206250 |
| NIH Device Record Key | 2194172f-1574-49b3-878f-c4ef23a66329 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stearleaf 1/4 and 3/16 AV Loop |
| Version Model Number | BEQ TOP 40008 |
| Catalog Number | 701066834 |
| 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 | 00607567206250 [Primary] |
| DWE | Tubing, Pump, Cardiopulmonary Bypass |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
[00607567206250]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-02 |
| Device Publish Date | 2016-02-14 |
| 10607567107301 - MEGA 8Fr. 50cc IAB | 2024-12-09 MEGA 8Fr. 50cc IAB |
| 10607567107318 - MEGA 8Fr. 50cc IAB (with APA) | 2024-12-09 MEGA 8Fr. 50cc IAB (with APA) |
| 10607567107479 - Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only | 2024-12-09 Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only |
| 10607567107516 - Catheter Extenders for 50cc IAB’s | 2024-12-09 Catheter Extenders for 50cc IAB’s |
| 10607567108001 - MEGA 8Fr. 50cc IAB (with Statlock) | 2024-12-09 MEGA 8Fr. 50cc IAB (with Statlock) |
| 10607567108018 - MEGA 8Fr. 50cc IAB (with Statlock & APA) | 2024-12-09 MEGA 8Fr. 50cc IAB (with Statlock & APA) |
| 10607567108063 - SENSATION PLUS 7.5Fr. 40cc IAB & Accessories | 2024-12-09 SENSATION PLUS 7.5Fr. 40cc IAB & Accessories |
| 10607567108605 - SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) | 2024-12-09 SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) |