Primary Device ID | 00841436104197 |
NIH Device Record Key | d95366ff-d204-4338-a5dc-3776a875fef6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NeoGuard™ |
Version Model Number | 610-836-5 |
Catalog Number | 610-836-5 |
Company DUNS | 134614411 |
Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. |
Device Count | 5 |
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 | |
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 | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 Inch |
Width | 17.72 Inch |
Length | 3.15 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 |
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 | 00841436104197 [Primary] |
GS1 | 80841436104193 [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 |
00841436110303 | Sterile (2.6 x 30cm) cover for use with BK Medical 2050, 2052 and 20R3 transducers |
00841436107273 | Non-sterile (2.6 x 30cm) cover |
00841436104210 | Non-sterile (4 x 30cm) cover |
00841436104203 | Non-sterile (2.6 x 30cm) cover |
00841436104197 | Non-sterile (2.6 x 30cm) cover |
00841436102179 | Non-sterile (2.0 x 30cm) cover |
00841436101813 | Non-sterile (2.6 x 30cm) cover |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() NEOGUARD 98394754 not registered Live/Pending |
Neology, Inc. 2024-02-06 |
![]() NEOGUARD 76371898 2767803 Live/Registered |
CIVCO Medical Instruments, Inc. 2002-02-19 |
![]() NEOGUARD 76364837 2618252 Live/Registered |
QUEST GROUP, LLC 2002-01-28 |
![]() NEOGUARD 76312277 2843494 Dead/Cancelled |
Intervet, Inc. 2001-09-14 |
![]() NEOGUARD 75350156 not registered Dead/Abandoned |
Intervet, Inc. 1997-09-02 |