| Primary Device ID | 10841436120897 |
| NIH Device Record Key | f0536d82-ec03-4c4c-9883-61440ea5fc1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Envision Ultrasound Pads/Covers |
| Version Model Number | H2O-014 |
| Catalog Number | H2O-014 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| Device Count | 20 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436120890 [Primary] |
| GS1 | 10841436120897 [Unit of Use] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
[10841436120897]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-01 |
| Device Publish Date | 2021-01-22 |
| 20841436113087 - GUS | 2024-09-17 G14TC-3-EU |
| 20841436122980 - Biopsy Bracket | 2024-09-17 Reusable non-sterile Verza™ bracket for use with FUJIFILM Healthcare MXL65RV and MXL65 transducers |
| 20841436125066 - Biopsy Bracket | 2024-09-17 Reusable non-sterile Verza™ bracket for use with Esaote L 8-24 transducers |
| 20841436122140 - Biopsy Bracket | 2024-06-28 Reusable non-sterile Verza™ bracket for use with Hologic® C9-2X transducers |
| 20841436123284 - Needle Guide Bracket | 2024-06-28 Reusable non-sterile Infiniti Plus™ bracket for use with Siemens HLX transducers |
| 00841436122214 - Needle Guide | 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare E72, E721, EC8, E8C-RS, E8CS, IC5-9-D, IC5-9H, IC9B-RS, MTZ, and MZ t |
| 00841436123051 - Needle Guide | 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare IC9 transducers. One-cell MEA: =80% embryo developed to expand cytob |
| 00841436123068 - Needle Guide | 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare RIC5-9-D, RIC5-9W-RS. RIC6-12-D and Samsung Medison EV3-10B, V5-9 tra |