| Primary Device ID | 10607567109596 |
| NIH Device Record Key | d1e53046-c081-4858-a995-7de7906d79be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEGA 7.5Fr. 40cc IAB with Accessories, US Only |
| Version Model Number | 0684-00-0295-01U |
| Catalog Number | 0684-00-0295-01U |
| 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 |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Catheter Gauge | 7.5 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10607567109596 [Primary] |
| DSP | System, Balloon, Intra-Aortic And Control |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
[10607567109596]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-12-06 |
| Device Publish Date | 2016-09-16 |
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| 10607567113760 - CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE | 2024-08-05 CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE |
| 10607567113777 - CABLE,LOW LEVEL OUTPUT,PHILIPS | 2024-08-05 CABLE,LOW LEVEL OUTPUT,PHILIPS |
| 10607567113784 - CABLE,LOW LEVEL OUTPUT,GE | 2024-08-05 |
| 10607567113807 - CABLE,INTERFACE,1/4-1/4",30' | 2024-08-05 |
| 10607567113814 - CABLE, INTERFACE .25" PLUG TO .25" PLUG 30 | 2024-08-05 CABLE, INTERFACE 1/4" PLUG TO 1/4" PLUG 30 |
| 10607567113821 - CABLE, INTERFACE 1/4” PLUG TO 1/8” PLUG, | 2024-08-05 |