Transducer Cover H2O-004TR

GUDID 00841436124164

Non-sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with Envision

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-surface ultrasound imaging transducer cover
Primary Device ID00841436124164
NIH Device Record Keya938d842-08e0-4862-b6ea-81f02b761a6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransducer Cover
Version Model NumberH2O-004TR
Catalog NumberH2O-004TR
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436124164 [Package]
Contains: 10841436124161
Package: [250 Units]
In Commercial Distribution
GS110841436124161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-16
Device Publish Date2024-02-08

On-Brand Devices [Transducer Cover]

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00841436110242Non-sterile (3.5 x 20cm) cover
00841436104142Non-sterile (3.2 tapered to 1.9 x 32cm) latex cover
00841436104135Non-sterile Series 620 (1.8 x 25.5cm) latex cover
00841436104128Non-sterile Series 500, 550 (1.3 x 5.8cm) latex cover (rolled)
00841436103664Non-sterile (1.5 x 7cm) latex fingercot
00841436103657Non-sterile (3.5 x 20cm) latex cover
00841436103633Non-sterile (3.5 x 20cm) latex cover
00841436101349Non-sterile (3.5 x 20cm) cover
00841436101332Non-sterile (3.5 x 20cm) latex cover
00841436100151Non-sterile (3.2 tapered to 1.9 x 32cm) latex cover
00841436114028Sterile (14x91.5cm) telescopically folded CIV-Flex cover with PEELSafe Advantage
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00841436101486Sterile (10 x 45cm) cover
00841436101479Sterile (8 x 45cm) cover
00841436101462Sterile (5 x 30cm) cover
00841436101387Sterile (22.9 x 61cm) polyethylene cover
00841436101370Sterile (17.8 x 61cm) flat-folded polyethylene cover
00841436101363Sterile (10.2 x 61cm) flat-folded polyethylene cover
00841436101356Sterile (5 x 61cm) flat-folded polyethylene cover
00841436100168Sterile (3.2 tapered to 1.9 x 32cm) latex cover with (7.6 x 244cm) polyehtylene cord cover, gel
00841436110310Sterile (3.2 tapered to 1.9 x 32cm) latex cover for use with BK Medical 1850, 8551, 8808, 8808e,
00841436110198Sterile (3.5 x 20cm) latex cover for use with BK Medical 5P1, 8538, 8545, 8547, 8551, 8553, 8556
00841436104685Sterile (3.2 tapered to 1.9 x 32cm) latex cover
00841436103596Sterile (3.5 x 20cm) latex cover
00841436103565Sterile (15.3 x 83.8cm) flat-folded polyethylene cover
00841436103091Sterile (17.8 x 61cm) flat-folded cover
00841436102940Sterile (10.2 x 147cm) telescopically-folded cover
00841436102933Sterile (8.9 x 91.5cm) telescopically-folded cover
00841436102926Sterile (14 x 147cm) telescopically-folded cover
00841436102919Sterile (14 x 91.5cm) telescopically-folded cover
00841436102902Sterile (14 x 61cm) flat-folded cover
00841436102322Sterile (3.5 x 20cm) latex cover
00841436121651Non-sterile (15.2x244cm) polyethylene telescopically-folded cover
00841436114042Sterile (14x147cm) telescopically folded CIV-Flex cover with PEELSafe Advantage
00841436121873Non-sterile (14 x 243.8cm) CIV-Flex telescopically-folded cover
00841436121866Non-sterile (14 x 61cm) CIV-Flex telescopically-folded cover
00841436121859Non-sterile (14 x 30.5cm) CIV-Flex telescopically-folded cover
00841436122641Sterile (15.2 x 25.4cm) flat-folded polyethylene cover
00841436125086Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision
00841436125079Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision
00841436124263Non-sterile (14 x 244cm) telescopically- folded CIV-Flex cover with Envision
00841436124256Non-sterile (14 x 147cm) telescopically- folded CIV-Flex cover with Envision
00841436124249Non-sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with Envision
00841436124232Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision
00841436124225Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision
00841436124218Non-sterile (14 x 30cm) telescopically- folded CIV-Flex cover with Envision
00841436124201Non-sterile (14 x 244cm) telescopically- folded CIV-Flex cover with Envision
00841436124195Non-sterile (14 x 244cm) telescopically- folded CIV-Flex cover with Envision

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