TACVAC 510-0006-01
GUDID B3945100006010
Portable Battery Powered Suction Device
ATHENA GTX, INC.
Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric Emergency airway clearance suction system, electric| Primary Device ID | B3945100006010 |
| NIH Device Record Key | dd371c9c-0261-43c8-8bb7-7b13b64c5e9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TACVAC |
| Version Model Number | Collection Unit |
| Catalog Number | 510-0006-01 |
| Company DUNS | 048031913 |
| Company Name | ATHENA GTX, INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com | |
| Phone | 515-288-3360 |
| info@athenagtx.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B3945100006010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153459
FDA Product Code
| BTA | Pump, Portable, Aspiration (Manual Or Powered) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-08-23 |
| Device Publish Date | 2017-12-06 |
On-Brand Devices [TACVAC]
| B3945300021010 | Portable Battery Powered Suction Device |
| B3945100006010 | Portable Battery Powered Suction Device |
Trademark Results [TACVAC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TACVAC 86795941 5205632 Live/Registered |
Athena GTX, Inc. 2015-10-22 |
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