Scanning Kit 612-056

GUDID 00841436104791

Non-sterile scanning kit with extension tube, (60cc) syringe, 3-way stopcock, latex covers (24) and o-rings (40)

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-surface ultrasound imaging transducer cover
Primary Device ID00841436104791
NIH Device Record Key5d0c8fed-58c0-4a9f-a213-165df37dbd37
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanning Kit
Version Model Number612-056
Catalog Number612-056
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com

Device Dimensions

Total Volume60 Milliliter
Length6.37 Inch
Total Volume60 Milliliter
Length6.37 Inch
Total Volume60 Milliliter
Length6.37 Inch
Total Volume60 Milliliter
Length6.37 Inch
Total Volume60 Milliliter
Length6.37 Inch
Total Volume60 Milliliter
Length6.37 Inch
Total Volume60 Milliliter
Length6.37 Inch
Total Volume60 Milliliter
Length6.37 Inch
Total Volume60 Milliliter
Length6.37 Inch
Total Volume60 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436104791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-08-22

On-Brand Devices [Scanning Kit]

00841436108751Reusable non-sterile standoff with (2.6 x 30cm) latex covers (10) for use with BK Medical Type 8
00841436104791Non-sterile scanning kit with extension tube, (60cc) syringe, 3-way stopcock, latex covers (24)
00841436103626Non-sterile extension tube, (60cc) syringe and 3-way stopcock
00841436101493Non-sterile (2.0 x 30cm) NeoGuard™

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.