Envision Transducer Cover H2O-017, H2O-017-5

GUDID 00841436120623

Sterile (14x244cm) CIV-flex cover with Enviision saline wipe

CIVCO MEDICAL INSTRUMENTS CO., INC.

Intraoperative ultrasound imaging transducer cover
Primary Device ID00841436120623
NIH Device Record Keyb791d58e-5107-4381-a2fc-3fcb70d26a79
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnvision Transducer Cover
Version Model NumberH2O-017
Catalog NumberH2O-017, H2O-017-5
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 Latextrue
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

Device Dimensions

Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 Centimeter
Length14 Centimeter
Width244 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
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
GS100841436120616 [Package]
Package: [5 Units]
In Commercial Distribution
GS100841436120623 [Package]
Contains: 10841436120620
Package: [24 Units]
In Commercial Distribution
GS110841436120620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

[00841436120623]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-29
Device Publish Date2021-01-21

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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