Scanning Kit 610-224

GUDID 00841436103626

Non-sterile extension tube, (60cc) syringe and 3-way stopcock

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-surface ultrasound imaging transducer cover
Primary Device ID00841436103626
NIH Device Record Key96f66315-96ee-449e-960a-d81bad7543a1
Commercial Distribution Discontinuation2020-12-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameScanning Kit
Version Model Number610-224
Catalog Number610-224
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 Latexfalse
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

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

Operating and Storage Conditions

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
GS100841436103626 [Package]
Contains: 10841436103623
Package: [5 Units]
Discontinued: 2020-12-17
Not in Commercial Distribution
GS110841436103623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYDGenerator, low voltage, therapeutic x-ray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-09-03
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™

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