DEVICE: Envision Transducer Cover (10841436120637)

Device Identifier (DI) Information

Envision Transducer Cover
H2O-018
In Commercial Distribution
H2O-018
CIVCO MEDICAL INSTRUMENTS CO., INC.
10841436120637
GS1

1
134614411 *Terms of Use
Sterile (14x244cm) CIV-flex cover with Enviision
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44713 Body-surface ultrasound imaging transducer cover
A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ITX Transducer, ultrasonic, diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K190802 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight
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Clinically Relevant Size

[?]
Size Type Text
Length: 14 Centimeter
Width: 244 Centimeter
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Device Record Status

77bab400-e8e6-49ee-ab89-fd56a626e836
September 06, 2021
2
January 21, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00841436120630 24 10841436120637 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(319)248-6502
regulatory@civco.com
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