Scanning Kit EA4015

GUDID 00841436108751

Reusable non-sterile standoff with (2.6 x 30cm) latex covers (10) for use with BK Medical Type 8558 and 8658 7.5 Bi-Plane transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-orifice ultrasound imaging transducer cover, image-enhancement
Primary Device ID00841436108751
NIH Device Record Keydb12c8e6-41e7-40fb-abb0-be2feabefd88
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanning Kit
Version Model NumberEA4015
Catalog NumberEA4015
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 Usefalse
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

Width2.6 Centimeter
Length30 Centimeter
Width2.6 Centimeter
Length30 Centimeter
Width2.6 Centimeter
Length30 Centimeter
Width2.6 Centimeter
Length30 Centimeter
Width2.6 Centimeter
Length30 Centimeter
Width2.6 Centimeter
Length30 Centimeter
Width2.6 Centimeter
Length30 Centimeter
Width2.6 Centimeter
Length30 Centimeter
Width2.6 Centimeter
Length30 Centimeter
Width2.6 Centimeter

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
GS100841436108751 [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™

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