Connector Cover 608-001, 608-002

GUDID 00841436101219

Sterile (20.3 tapered to 10.8 x 183cm) polyethylene accordion-folded cover for use with SOUNDSTAR® eco Catheter Family Connectors

CIVCO MEDICAL INSTRUMENTS CO., INC.

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Primary Device ID00841436101219
NIH Device Record Key1030ac52-848a-4768-a780-bd91b8061ac5
Commercial Distribution StatusIn Commercial Distribution
Brand NameConnector Cover
Version Model Number608-001, 608-002
Catalog Number608-001, 608-002
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

Width8 Inch
Length72 Inch
Width8 Inch
Length72 Inch
Width8 Inch
Length72 Inch
Width8 Inch
Length72 Inch
Width8 Inch
Length72 Inch
Width8 Inch
Length72 Inch
Width8 Inch
Length72 Inch
Width8 Inch
Length72 Inch
Width8 Inch
Length72 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
GS100841436101219 [Package]
Contains: 10841436101216
Package: [12 Units]
In Commercial Distribution
GS100841436101226 [Package]
Contains: 10841436101216
Package: [5 Units]
In Commercial Distribution
GS110841436101216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436101219]

Ethylene Oxide


[00841436101219]

Ethylene Oxide


[00841436101219]

Ethylene Oxide


[00841436101219]

Ethylene Oxide


[00841436101219]

Ethylene Oxide


[00841436101219]

Ethylene Oxide


[00841436101219]

Ethylene Oxide


[00841436101219]

Ethylene Oxide


[00841436101219]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-03
Device Publish Date2017-08-22

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