| Primary Device ID | 00841436114950 |
| NIH Device Record Key | e7082f7b-c68b-440b-805e-2a9ec35111b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | envision Ultrasound Pad |
| Version Model Number | H2O-006, H2O-006-5 |
| Catalog Number | H2O-006, H2O-006-5 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., 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 | 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 | false |
| 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 |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Width | 3.25 Inch |
| Length | 5 Inch |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436114943 [Package] Contains: 10841436114940 Package: [24 Units] In Commercial Distribution |
| GS1 | 00841436114950 [Package] Contains: 00841436114943 Package: [5 Units] In Commercial Distribution |
| GS1 | 10841436114940 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
[00841436114950]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-27 |
| Device Publish Date | 2019-06-19 |
| 00841436114950 | Sterile (8.25 x 12.7cm) hydrophilic ultrasound pad with adhesive |
| 00841436114868 | Sterile (8.25 x 12.7cm) hydrophilic scanning pad with adhesive |