Cord Cover UA0004
GUDID 00841436110174
Sterile (7.6 x 244cm) polyethylene cord cover
CIVCO MEDICAL INSTRUMENTS CO., INC.
Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use| Primary Device ID | 00841436110174 |
| NIH Device Record Key | 8d546078-d83b-4113-9620-c70c7597548d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cord Cover |
| Version Model Number | UA0004 |
| Catalog Number | UA0004 |
| 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 |
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 |
Device Dimensions
| Length | 96 Inch |
| Width | 3 Inch |
| Length | 96 Inch |
| Width | 3 Inch |
| Length | 96 Inch |
| Width | 3 Inch |
| Length | 96 Inch |
| Width | 3 Inch |
| Length | 96 Inch |
| Width | 3 Inch |
| Length | 96 Inch |
| Width | 3 Inch |
| Length | 96 Inch |
| Width | 3 Inch |
| Length | 96 Inch |
| Width | 3 Inch |
| Length | 96 Inch |
| Width | 3 Inch |
| Length | 96 Inch |
| Width | 3 Inch |
Operating and Storage Conditions
| 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 | 00841436110174 [Package] Contains: 10841436110171 Package: [24 Units] In Commercial Distribution |
| GS1 | 10841436110171 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K970513
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436110174]
Ethylene Oxide
[00841436110174]
Ethylene Oxide
[00841436110174]
Ethylene Oxide
[00841436110174]
Ethylene Oxide
[00841436110174]
Ethylene Oxide
[00841436110174]
Ethylene Oxide
[00841436110174]
Ethylene Oxide
[00841436110174]
Ethylene Oxide
[00841436110174]
Ethylene Oxide
[00841436110174]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-09-06 |
| Device Publish Date | 2017-08-22 |
On-Brand Devices [Cord Cover]
| 00841436101400 | Sterile (7.6 x 244cm) polyethylene cover |
| 00841436110174 | Sterile (7.6 x 244cm) polyethylene cord cover |
Trademark Results [Cord Cover]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORD COVER 76478615 not registered Dead/Abandoned |
Sandel Medical Industries LLC 2002-12-27 |
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