WiCap 520-0015-01
GUDID B3945200015010
Pulse-Ox Accessory
ATHENA GTX, INC.
Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter| Primary Device ID | B3945200015010 |
| NIH Device Record Key | 6c41ccb0-647c-488b-b98e-fc1b14f5ac68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WiCap |
| Version Model Number | XPOD Accessory |
| Catalog Number | 520-0015-01 |
| 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 | false |
| 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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B3945200015010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160582
FDA Product Code
| DQA | Oximeter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-12-06 |
On-Brand Devices [WiCap]
| B3945200015010 | Pulse-Ox Accessory |
| B3945000016010 | Patient Monitor |
Trademark Results [WiCap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WICAP 86517970 4807818 Live/Registered |
Athena GTX, Inc. 2015-01-29 |
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