DEVICE: Y-Port Feeding Adapter (00842071114718)

Device Identifier (DI) Information

Y-Port Feeding Adapter
E4-2024-ISOSAF
Not in Commercial Distribution
E4-2024-ISOSAF, 4-2024-ISOSAF
APPLIED MEDICAL TECHNOLOGY, INC.
00842071114718
GS1
July 05, 2023
1
038101861 *Terms of Use
24 FR Y-Port Replacement (ISOSAF, Pouched)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
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?
64469 ENFit/non-ISO80369-standardized 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 connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KNT Tubes, Gastrointestinal (And Accessories)
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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

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

[?]
Size Type Text
Catheter Gauge: 24 French
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Device Record Status

690b580f-ee1b-4623-b9f8-858302073964
July 06, 2023
4
November 18, 2016
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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
00842071114886 10 00842071114718 2023-07-05 Not in Commercial Distribution Box (4-2024-ISOSAF)
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Secondary DI

[?]
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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(440) 717-4000
cs@appliedmedical.net
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