Hummingbird® H610MR
GUDID 00851680007182
H610MR Hummingbird SynergyDuo Ventricular Catheter Kit
INNERSPACE NEURO SOLUTIONS, INC.
Intracerebral sensor catheter| Primary Device ID | 00851680007182 |
| NIH Device Record Key | c79fc1d8-ff46-40c3-9a9f-c67998c17f2d |
| Commercial Distribution Discontinuation | 2018-03-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Hummingbird® |
| Version Model Number | H610MR |
| Catalog Number | H610MR |
| Company DUNS | 080333634 |
| Company Name | INNERSPACE NEURO SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
Device Dimensions
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
| Catheter Gauge | 8.5 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851680007182 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083378
FDA Product Code
| GWM | Device, Monitoring, Intracranial Pressure |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-28 |
On-Brand Devices [Hummingbird®]
| 00851680007205 | H610 Hummingbird SynergyDuo Ventricular Catheter Kit |
| 00851680007199 | STC - Skull Thickness Caliper |
| 00851680007182 | H610MR Hummingbird SynergyDuo Ventricular Catheter Kit |
| 00851680007175 | H110MR Hummingbird Parenchymal Catheter Kit |
| 00851680007168 | H310 Hummingbird Tunneled Ventricular Catheter Kit |
| 00851680007151 | Hummingbird ICP Control Module with Patient Cable Module |
Trademark Results [Hummingbird]
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