DEVICE: Enteral (05060590883648)

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Device Record History
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Device Identifier (DI) Information
Enteral
PFCO-50NS
In Commercial Distribution
PFCO-50NS
GBUK ENTERAL LIMITED
05060590883648
GS1

50
216643186 *Terms of Use
Enteral, Syringe Accessories, Push Fit Cap, Single Use
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Device Characteristics
MR Safe
No
No
Yes
No
No
No
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?
65012 ENFit-formatted protective cap
A small, noninvasive, closed-ended, ENFit-formatted (ISO 80369-3) attachment intended to be attached to an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KYX DISPENSER, LIQUID MEDICATION
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
65bfe363-a86e-4bfe-9341-2cd361350077
November 09, 2022
1
November 01, 2022
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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
05060590883969 12 05060590883921 In Commercial Distribution Case
05060590883921 4 05060590883648 In Commercial Distribution Bag in Box
05060590883983 10 05060590883648 In Commercial Distribution Bag in Box
05060590885352 8 05060590883983 In Commercial Distribution Case
05060590887790 80 05060590883648 In Commercial Distribution Box
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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: 45060590883646 CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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