| Primary Device ID | B3945700047010 |
| NIH Device Record Key | f400d073-e8a1-45b3-9df3-186cf5b87bac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WVSM Wireless Vital Signs Monitor |
| Version Model Number | miniCap Mainstream |
| Catalog Number | 570-0047-01 |
| 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 |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com | |
| Phone | 5152883360 |
| info@athenagtx.com |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B3945700047010 [Primary] |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-08 |
| Device Publish Date | 2021-10-29 |
| B3945700025050 | BP Extension Hose-5 ft |
| B3945700025040 | BP Extension Hose-4 ft |
| B3945700025030 | BP Extension Hose-3 ft |
| B3945700025020 | BP Extension Hose-2 ft |
| B3945700025010 | BP Extension Hose-1 ft |
| B3945700024010 | Shoulder Strap-Black |
| B3945700004020 | ECG Lead Wires - Bonded |
| B3945700004010 | ECG Lead Wires - Unbonded |
| B3945500039010 | USB Data Cable |
| B3945300002010 | A/C Power Brick |
| B3945100004040 | Custom Pouch for 2 WVSMs |
| B3945100004030 | Carry Case for 10 WVSMs |
| B3945100004020 | Carry Case for 4 WVSMs |
| B3945100004010 | Carry Case for 2 WVSMs |
| B3945000025060 | Carry case/Charger for 10 WVSMs - Graphite |
| B3945000025050 | Carry case/Charger for 10 WVSMs - Silver |
| B3945000025040 | Carry case/Charger for 10 WVSMs - Yellow |
| B3945000025030 | Carry case/Charger for 10 WVSMs - Orange |
| B3945000025020 | Carry case/Charger for 10 WVSMs - Olive |
| B3945000025010 | Carry case/Charger for 10 WVSMs - Black |
| B3945000001120 | Wireless Patient Monitor |
| B3945000001010 | Wireless Patient Monitor |
| B3944670006010 | A/C Power Cord |
| B3944060005010 | BP Cuff Clip |
| B3943950006000 | WVSM Management Suite - iOS |
| B3943900004000 | WVSM Management Suite - PC |
| B3945300025010 | AC/DC Power Supply |
| B3944670036010 | A/C Power Cord - Israel |
| B3944670019020 | A/C Power Cord |
| B3945700047020 | miniCap Sidestream |
| B3945700047010 | miniCap Mainstream |
| B394530023020 | WVSM Aux Battery (Angled) |
| B3945300023010 | WVSM Aux Battery (Straight) |
| B3945000034040 | Wireless Patient Monitor |
| B3945000034030 | Wireless Patient Monitor |
| B3945000034020 | Wireless Patient Monitor |
| B3945000034010 | Wireless Patient Monitor |
| B3944670019010 | WVSM Power Cord (US) |
| B3944670063010 | C13 AC Power Cord to European C7 |