| Primary Device ID | 00841436114974 |
| NIH Device Record Key | 57e1f626-c766-47e9-8176-c27f05294cba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | envision Transducer Cover |
| Version Model Number | H2O-008, H2O-008-5 |
| Catalog Number | H2O-008, H2O-008-5 |
| 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 | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Width | 24 Inch |
| Length | 5.5 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| 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 | 00841436114974 [Package] Contains: 10841436114971 Package: [24 Units] In Commercial Distribution |
| GS1 | 00841436114981 [Package] Package: [5 Units] In Commercial Distribution |
| GS1 | 10841436114971 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436114974]
Ethylene Oxide
[00841436114974]
Ethylene Oxide
[00841436114974]
Ethylene Oxide
[00841436114974]
Ethylene Oxide
[00841436114974]
Ethylene Oxide
[00841436114974]
Ethylene Oxide
[00841436114974]
Ethylene Oxide
[00841436114974]
Ethylene Oxide
[00841436114974]
Ethylene Oxide
[00841436114974]
Ethylene Oxide
[00841436114974]
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 |
| 00841436115025 | Sterile (14 x 147cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophil |
| 00841436115001 | Sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophi |
| 00841436114974 | Sterile (14 x 60.9cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophi |
| 00841436114936 | Sterile (14 x 147cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophil |
| 00841436114912 | Sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophi |
| 00841436114882 | Sterile (14 x 60.9cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophi |
| 00841436120630 | Sterile (14x244cm) CIV-flex cover with Enviision |
| 00841436120623 | Sterile (14x244cm) CIV-flex cover with Enviision saline wipe |
| 00841436120609 | Sterile (14x30cm) CIV-flex cover with Enviision saline wipe |
| 00841436120586 | Sterile (14x30cm) CIV-flex cover with Enviision |
| 00841436122023 | Sterile (14x30cm) telescopically-folded CIV-Flex cover with Envision |
| 00841436122030 | Sterile (14x30cm) telescopically-folded CIV-Flex cover with Envision |