| Primary Device ID | 00841436101677 |
| NIH Device Record Key | efbf7eca-cdf6-4b2e-8009-399c0e8342a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROcovers™ |
| Version Model Number | 610-101 |
| Catalog Number | 610-101 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| Device Count | 24 |
| 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 | true |
| 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 | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| Length | 30 Centimeter |
| Width | 2.6 Centimeter |
| 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 |
| 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 | 00841436101677 [Primary] |
| GS1 | 80841436101673 [Unit of Use] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-22 |
| 00841436110273 | Non-sterile (2.6 x 30cm) cover for use with BK Medical 2050, 2052 and 20R3 transducers |
| 00841436101677 | Non-sterile (2.6 x 30cm) cover |
| 00841436101448 | Non-sterile (4 x 30cm) latex cover |
| 00841436101431 | Non-sterile (2.6 x 20cm) latex cover |
| 00841436101424 | Non-sterile (2 x 20cm) latex cover |
| 00841436101455 | Sterile (4 x 30cm) latex cover |
| 00841436110181 | Sterile (2.6 x 30cm) latex cover for use with BK Medical 2050, 2052, 20R3, 8544, 8554, 8558, 856 |
| 00841436103589 | Sterile (2.6 x 30cm) latex cover |
| 00841436103572 | Sterile (2 x 30cm) latex cover |
| 00841436101523 | Sterile (2.6 x 20cm) cover |
| 00841436101516 | Sterile (2 x 20cm) latex cover |