WiCap 520-0015-01
GUDID B3945200015010
Pulse-Ox Accessory
ATHENA GTX, INC.
Pulse oximeter, line-powered| 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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