| Primary Device ID | 00607567208421 |
| NIH Device Record Key | 73cd9797-3efb-470a-ae69-928d9b24f404 |
| Commercial Distribution Discontinuation | 2016-02-20 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Sanford Children's Hospital Adaptation Pack |
| Version Model Number | BEQ TOP 53400 |
| Catalog Number | 709000213 |
| 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 |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607567208421 [Primary] |
| DWE | Tubing, Pump, Cardiopulmonary Bypass |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
[00607567208421]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-02 |
| Device Publish Date | 2016-02-20 |