envision Transducer Cover H2O-004. H2O-004-5

GUDID 00841436114912

Sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophilic ultrasound pad

CIVCO MEDICAL INSTRUMENTS CO., INC.

Intraoperative ultrasound imaging transducer cover
Primary Device ID00841436114912
NIH Device Record Key0765b38e-fb7b-470f-93ad-947b4702826c
Commercial Distribution StatusIn Commercial Distribution
Brand Nameenvision Transducer Cover
Version Model NumberH2O-004. H2O-004-5
Catalog NumberH2O-004. H2O-004-5
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
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
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

Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch
Length5.5 Inch
Width36 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436114905 [Package]
Contains: 10841436114902
Package: [24 Units]
In Commercial Distribution
GS100841436114912 [Package]
Contains: 00841436114905
Package: [5 Units]
In Commercial Distribution
GS100841436120210 [Package]
Package: [120 Units]
In Commercial Distribution
GS110841436114902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

[00841436114912]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-27
Device Publish Date2019-06-19

On-Brand Devices [envision Transducer Cover]

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