| Primary Device ID | 10607567108025 |
| NIH Device Record Key | e954793c-b9ee-4581-a325-8df157dc4725 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs |
| Version Model Number | 0884-00-0019-21 |
| Catalog Number | 0884-00-0019-21 |
| 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 |
| 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 |
| 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 |
| 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 | 10607567108025 [Primary] |
| DSP | System, Balloon, Intra-Aortic And Control |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
Ethylene Oxide
[10607567108025]
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 |
| 10607567108025 | Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs |
| 10607567114224 | Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs |