| Primary Device ID | 10607567108599 |
| NIH Device Record Key | d743e52a-7d2c-41bd-b60b-b5a4dd05f112 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr |
| Version Model Number | 0884-00-0019-23 |
| Catalog Number | 0884-00-0019-23 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com | |
| Phone | 888-627-8383 |
| customer.support@maquet.com |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10607567108599 [Primary] |
| DSP | System, Balloon, Intra-Aortic And Control |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
[10607567108599]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2016-09-16 |
| 10607567108599 | Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr 50cc IAB |
| 10607567114248 | Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr 50cc IAB |