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 ID	00841436101219
NIH Device Record Key	1030ac52-848a-4768-a780-bd91b8061ac5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Connector Cover
Version Model Number	608-001, 608-002
Catalog Number	608-001, 608-002
Company DUNS	134614411
Company Name	CIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count	1
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

Customer Support Contacts

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

Device Dimensions

Width	8 Inch
Length	72 Inch
Width	8 Inch
Length	72 Inch
Width	8 Inch
Length	72 Inch
Width	8 Inch
Length	72 Inch
Width	8 Inch
Length	72 Inch
Width	8 Inch
Length	72 Inch
Width	8 Inch
Length	72 Inch
Width	8 Inch
Length	72 Inch
Width	8 Inch
Length	72 Inch

Operating and Storage Conditions

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 Identifiers

Device Issuing Agency	Device ID
GS1	00841436101219 [Package] Contains: 10841436101216 Package: [12 Units] In Commercial Distribution
GS1	00841436101226 [Package] Contains: 10841436101216 Package: [5 Units] In Commercial Distribution
GS1	10841436101216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K970513

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[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 Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-09-03
Device Publish Date	2017-08-22

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