| Primary Device ID | 00841436118651 |
| NIH Device Record Key | 4b6d96d7-91ba-4f07-86d9-920b5f20db87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transducer Cover |
| Version Model Number | 610-2328, 610-2328-5 |
| Catalog Number | 610-2328, 610-2328-5 |
| 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 | 96 Inch |
| Length | 5.5 Inch |
| Width | 96 Inch |
| Length | 5.5 Inch |
| Width | 96 Inch |
| Length | 5.5 Inch |
| Width | 96 Inch |
| Length | 5.5 Inch |
| Width | 96 Inch |
| Length | 5.5 Inch |
| Width | 96 Inch |
| Length | 5.5 Inch |
| Width | 96 Inch |
| Length | 5.5 Inch |
| Width | 96 Inch |
| Length | 5.5 Inch |
| Width | 96 Inch |
| Length | 5.5 Inch |
| Width | 96 Inch |
| Length | 5.5 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 | 00841436118644 [Package] Contains: 10841436118641 Package: [24 Units] In Commercial Distribution |
| GS1 | 00841436118651 [Package] Contains: 00841436118644 Package: [5 Units] In Commercial Distribution |
| GS1 | 10841436118641 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
[00841436118651]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-01 |
| Device Publish Date | 2019-06-21 |
| 00841436118651 | Sterile (14 x 244cm) telescopically-folded CIV-Flex cover with PEELSafe Advantage |
| 00841436110266 | Non-sterile (3.2 tapered to 1.9 x 32cm) latex covers for use with BK Medical 8508, 8808, 8808e, |
| 00841436110242 | Non-sterile (3.5 x 20cm) cover |
| 00841436104142 | Non-sterile (3.2 tapered to 1.9 x 32cm) latex cover |
| 00841436104135 | Non-sterile Series 620 (1.8 x 25.5cm) latex cover |
| 00841436104128 | Non-sterile Series 500, 550 (1.3 x 5.8cm) latex cover (rolled) |
| 00841436103664 | Non-sterile (1.5 x 7cm) latex fingercot |
| 00841436103657 | Non-sterile (3.5 x 20cm) latex cover |
| 00841436103633 | Non-sterile (3.5 x 20cm) latex cover |
| 00841436101349 | Non-sterile (3.5 x 20cm) cover |
| 00841436101332 | Non-sterile (3.5 x 20cm) latex cover |
| 00841436100151 | Non-sterile (3.2 tapered to 1.9 x 32cm) latex cover |
| 00841436114028 | Sterile (14x91.5cm) telescopically folded CIV-Flex cover with PEELSafe Advantage |
| 10841436108758 | Sterile (2.6 x 30cm) latex cover for use with BK Medical 8558 and 8658 7.5 Bi-Plane transducers |
| 00841436101486 | Sterile (10 x 45cm) cover |
| 00841436101479 | Sterile (8 x 45cm) cover |
| 00841436101462 | Sterile (5 x 30cm) cover |
| 00841436101387 | Sterile (22.9 x 61cm) polyethylene cover |
| 00841436101370 | Sterile (17.8 x 61cm) flat-folded polyethylene cover |
| 00841436101363 | Sterile (10.2 x 61cm) flat-folded polyethylene cover |
| 00841436101356 | Sterile (5 x 61cm) flat-folded polyethylene cover |
| 00841436100168 | Sterile (3.2 tapered to 1.9 x 32cm) latex cover with (7.6 x 244cm) polyehtylene cord cover, gel |
| 00841436110310 | Sterile (3.2 tapered to 1.9 x 32cm) latex cover for use with BK Medical 1850, 8551, 8808, 8808e, |
| 00841436110198 | Sterile (3.5 x 20cm) latex cover for use with BK Medical 5P1, 8538, 8545, 8547, 8551, 8553, 8556 |
| 00841436104685 | Sterile (3.2 tapered to 1.9 x 32cm) latex cover |
| 00841436103596 | Sterile (3.5 x 20cm) latex cover |
| 00841436103565 | Sterile (15.3 x 83.8cm) flat-folded polyethylene cover |
| 00841436103091 | Sterile (17.8 x 61cm) flat-folded cover |
| 00841436102940 | Sterile (10.2 x 147cm) telescopically-folded cover |
| 00841436102933 | Sterile (8.9 x 91.5cm) telescopically-folded cover |
| 00841436102926 | Sterile (14 x 147cm) telescopically-folded cover |
| 00841436102919 | Sterile (14 x 91.5cm) telescopically-folded cover |
| 00841436102902 | Sterile (14 x 61cm) flat-folded cover |
| 00841436102322 | Sterile (3.5 x 20cm) latex cover |
| 00841436121651 | Non-sterile (15.2x244cm) polyethylene telescopically-folded cover |
| 00841436114042 | Sterile (14x147cm) telescopically folded CIV-Flex cover with PEELSafe Advantage |
| 00841436121873 | Non-sterile (14 x 243.8cm) CIV-Flex telescopically-folded cover |
| 00841436121866 | Non-sterile (14 x 61cm) CIV-Flex telescopically-folded cover |
| 00841436121859 | Non-sterile (14 x 30.5cm) CIV-Flex telescopically-folded cover |
| 00841436122641 | Sterile (15.2 x 25.4cm) flat-folded polyethylene cover |
| 00841436125086 | Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision |
| 00841436125079 | Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision |
| 00841436124263 | Non-sterile (14 x 244cm) telescopically- folded CIV-Flex cover with Envision |
| 00841436124256 | Non-sterile (14 x 147cm) telescopically- folded CIV-Flex cover with Envision |
| 00841436124249 | Non-sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with Envision |
| 00841436124232 | Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision |
| 00841436124225 | Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision |
| 00841436124218 | Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision |
| 00841436124201 | Non-sterile (14 x 244cm) telescopically- folded CIV-Flex cover with Envision |
| 00841436124195 | Non-sterile (14 x 244cm) telescopically- folded CIV-Flex cover with Envision |