DEVICE: Enteral ENFit Transition Connector with cap for medication port (08056093720112)

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Device Record History
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Device Identifier (DI) Information
Enteral ENFit Transition Connector with cap for medication port
F00073
Not in Commercial Distribution

CEDIC SRL
08056093720112
GS1
June 03, 2021
1
429471691 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
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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?
64470 ENFit/Luer linear connector
A small, non-powered, noninvasive, tubular, two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a Luer connection (either lock or slip) at the other end, intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with ENFit connection with another device that has Luer connection. It does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
PIO Enteral Specific Transition Connectors
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
2e144f82-39c6-43d0-9cdf-a15974fd2b39
June 07, 2021
3
December 28, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
08056093720136 24 08056093720129 2021-06-03 Not in Commercial Distribution
08056093720129 30 08056093720112 2021-06-03 Not in Commercial Distribution
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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