envision Transducer Cover H2O-005, H2O-005-5

GUDID 00841436114936

Sterile (14 x 147cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophilic ultrasound pad

CIVCO MEDICAL INSTRUMENTS CO., INC.

Intraoperative ultrasound imaging transducer cover

Primary Device ID	00841436114936
NIH Device Record Key	78484fe2-9bb2-44f9-9077-957e99c65dc2
Commercial Distribution Status	In Commercial Distribution
Brand Name	envision Transducer Cover
Version Model Number	H2O-005, H2O-005-5
Catalog Number	H2O-005, H2O-005-5
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
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
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	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch
Length	5.5 Inch
Width	58 Inch

Operating and Storage Conditions

Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436114929 [Package] Contains: 10841436114926 Package: [24 Units] In Commercial Distribution
GS1	00841436114936 [Package] Contains: 00841436114929 Package: [5 Units] In Commercial Distribution
GS1	10841436114926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K190802

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

[00841436114936]

Ethylene Oxide

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-06-27
Device Publish Date	2019-06-19

On-Brand Devices [envision Transducer Cover]

00841436115025	Sterile (14 x 147cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophil
00841436115001	Sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophi
00841436114974	Sterile (14 x 60.9cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophi
00841436114936	Sterile (14 x 147cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophil
00841436114912	Sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophi
00841436114882	Sterile (14 x 60.9cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophi
00841436120630	Sterile (14x244cm) CIV-flex cover with Enviision
00841436120623	Sterile (14x244cm) CIV-flex cover with Enviision saline wipe
00841436120609	Sterile (14x30cm) CIV-flex cover with Enviision saline wipe
00841436120586	Sterile (14x30cm) CIV-flex cover with Enviision
00841436122023	Sterile (14x30cm) telescopically-folded CIV-Flex cover with Envision
00841436122030	Sterile (14x30cm) telescopically-folded CIV-Flex cover with Envision