| Primary Device ID | 00841436103763 |
| NIH Device Record Key | d10198d9-af9e-4f09-8665-9e3b4297e0fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CIV-Flex™ Transducer Cover |
| Version Model Number | 610-575, 610-575-5, 610-575B |
| Catalog Number | 610-575, 610-575-5, 610-575B |
| 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 |
| Width | 5.5 Inch |
| Length | 58 Inch |
| Width | 5.5 Inch |
| Length | 58 Inch |
| Width | 5.5 Inch |
| Length | 58 Inch |
| Width | 5.5 Inch |
| Length | 58 Inch |
| Width | 5.5 Inch |
| Length | 58 Inch |
| Width | 5.5 Inch |
| Length | 58 Inch |
| Width | 5.5 Inch |
| Length | 58 Inch |
| Width | 5.5 Inch |
| Length | 58 Inch |
| Width | 5.5 Inch |
| Length | 58 Inch |
| Width | 5.5 Inch |
| Length | 58 Inch |
| 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 | 00841436103763 [Package] Contains: 10841436103777 Package: [5 Units] In Commercial Distribution |
| GS1 | 00841436103770 [Package] Contains: 10841436103777 Package: [24 Units] In Commercial Distribution |
| GS1 | 10841436103777 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436103763]
Ethylene Oxide
[00841436103763]
Ethylene Oxide
[00841436103763]
Ethylene Oxide
[00841436103763]
Ethylene Oxide
[00841436103763]
Ethylene Oxide
[00841436103763]
Ethylene Oxide
[00841436103763]
Ethylene Oxide
[00841436103763]
Ethylene Oxide
[00841436103763]
Ethylene Oxide
[00841436103763]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-09-06 |
| Device Publish Date | 2017-08-22 |
| 00841436104333 | Non-sterile (14 x 30cm) cover |
| 00841436103695 | Non-sterile (14 x 61cm) cover |
| 00841436103145 | Non-sterile (17.8 x 147cm) telescopically-folded cover |
| 00841436101721 | Non-sterile (10.2 x 147cm) telescopically-folded cover |
| 00841436101714 | Non-sterile (14 x 147cm) telescopically-folded cover |
| 00841436101325 | Non-sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover (no gel) |
| 00841436102650 | Non-sterile (3.8 tapered to 1.7 x 122cm) TEE cover on applicator |
| 00841436101622 | Sterile (3.8 tapered to 1.7 x 122cm) TEE cover on applicator |
| 80841436104636 | CIV-Flex Transducer Cover (14 x 147cm) - Qty: 5. FUJIFILM SonoSite, Inc L25 Needle Guide (18GA) |
| 00841436118248 | Sterile (10.1 tapered to 2.5 x 30.5cm) cover |
| 00841436110167 | Sterile (8.9 x 30cm) CIV-Flex™ cover |
| 00841436101639 | Non-sterile (3.8 tapered to 1.7 x 122cm) pediatric TEE cover on applicator, gel-filled syringe a |
| 00841436101301 | Sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover |
| 00841436101295 | Sterile (22.9 x 61cm) flat-folded cover |
| 00841436101288 | Sterile (17.8 x 61cm) flat-folded cover |
| 00841436101271 | Sterile (14 x 61cm) flat-folded cover |
| 00841436101264 | Sterile (8.9 x 61cm) flat-folded cover |
| 00841436119900 | 14 x 91.5cm telescopically-folded cover |
| 00841436110389 | Sterile (14 x 147cm) telescopically-folded cover for use with BK Medical 6C2, 6C2s, 9C2, 8801, 8 |
| 00841436110334 | Sterile (8.9 x 91.5cm) telescopically-folded cover for use with BK Medical 6C2s, 9C2, 14L3, 8559 |
| 00841436110327 | Sterile (14 x 91.5cm) telescopically-folded cover for use with BK Medical 6C2, 10L2w, 13L4w, 880 |
| 00841436110228 | Sterile (8.9 x 61cm) cover for use with BK Medical 6C2, 6C2s, 9C2, 14L3, 18L5, 8670, 8802, 8814, |
| 00841436110211 | Sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover for use with BK Medical 8544, 8554, 8557, |
| 00841436110204 | Sterile (14 x 61cm) cover for use with BK Medical 6C2, 10L2w, 13L4w, 8541, 8542, 8543, 8546, 854 |
| 10841436108604 | Sterile (14 x 30cm) cover, gel and bands |
| 10841436108598 | Sterile (14 x 147cm) telescopically-folded cover, gel and bands |
| 00841436104746 | Sterile (11.9 tapered to 3.8 x 91.5 cm) telescopically-folded cover |
| 00841436104470 | Sterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator |
| 00841436104289 | Non-sterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator |
| 00841436104227 | Non-sterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator, gel-filled syringe and bite bl |
| 00841436103923 | Sterile (8.9 x 91.5cm) telescopically-folded cover |
| 00841436103763 | Sterile (14 x 147cm) telescopically-folded cover |
| 00841436101905 | Sterile (14 x 91.5cm) telescopically-folded cover |
| 00841436103671 | Sterile (6 x 91.5cm) flat-folded cover |
| 00841436103114 | Sterile (7.4 tapered to 9.5 x 30.5cm) telescopically-folded transducer cover |
| 00841436103107 | Sterile (14 x 147cm) telescopically-folded cover |
| 00841436103084 | Sterile (14 x 30cm) cover |
| 00841436102629 | Sterile (17.8 x 91.5cm) telescopically-folded cover |
| 00841436102414 | Sterile (14 x 29.2cm) telescopically-folded wireless transducer cover |
| 00841436102124 | Sterile (17.8 x 244cm) telescopically-folded cover |
| 00841436102100 | Sterile (14 x 244cm) telescopically-folded cover |
| 00841436102094 | Sterile (10.2 x 244cm) telescopically-folded cover |
| 00841436101899 | Sterile (10.2 x 147cm) telescopically-folded cover |
| 00841436101592 | Sterile (17.8 x 147cm) telescopically-folded cover |
| 00841436101530 | Sterile (10.2 x 147cm) telescopically-folded cover |
| 00841436114820 | Sterile (11.9 tapered to 3.8x244cm) telescopically folded cover |
| 00841436114653 | 14x244cm telescopically folded cover |
| 00841436114639 | Sterile (10.1x244cm) telescopically folded cover with tapered end |
| 00841436114417 | 14x147cm telescopically folded cover |
| 80841436118596 | Non-sterile (6x91.5cm) flat folded cover |