Starter Kit H4908NF
GUDID 00841436109338
Reusable non-sterile Volume Navigation Sensor bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5) for use with GE Healthcare IC5-9-D transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
Ultrasound imaging system tracking holder, reusable| Primary Device ID | 00841436109338 |
| NIH Device Record Key | c1480385-1e50-4040-9a2f-8557ea3c1f99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Starter Kit |
| Version Model Number | H4908NF |
| Catalog Number | H4908NF |
| 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 | false |
| 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 |
Customer Support Contacts
| 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 | |
| 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 | |
| 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 |
Device Dimensions
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
| Length | 2.33 Inch |
| Height | 1.35 Inch |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436109338 [Primary] |
| GS1 | 20841436115418 [Direct Marking] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092619
FDA Product Code
| IYO | System, imaging, pulsed echo, ultrasonic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2017-08-22 |
On-Brand Devices [Starter Kit]
| 00841436109444 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436109437 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436109352 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436109345 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436109338 | Reusable non-sterile Volume Navigation Sensor bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex |
| 00841436109123 | Reusable non-sterile Volume Navigation Sensor bracket with (17.8 x 147cm) CIV-Flex™ covers (5 |
| 00841436108935 | Reusable non-sterile Volume Navigation Sensor bracket with (8.9 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436108904 | Reusable non-sterile Volume Navigation Sensor bracket with (9 x 91.5cm) CIV-Flex™ covers (5) f |
| 00841436109369 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
Trademark Results [Starter Kit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STARTER KIT 90670217 not registered Live/Pending |
Shenzhen Freenove Creative Technology Co., Ltd. 2021-04-25 |
 STARTER KIT 75645402 2428837 Dead/Cancelled |
Diagonale, Jeffrey Dean 1999-02-22 |
 STARTER KIT 75332952 not registered Dead/Abandoned |
Corinthian Group, The 1997-07-30 |
 STARTER KIT 75227177 not registered Dead/Abandoned |
Cliffco of Tampa Bay, Inc. 1997-01-17 |
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