DEVICE: Ameritus ENFit (10817522012384)

Device Identifier (DI) Information

Ameritus ENFit
ENF-Y80P-40
In Commercial Distribution
ENF-Y80P-40
KENTEC MEDICAL, INC.
10817522012384
GS1

1
066175613 *Terms of Use
8fr 40cm dual port feeding tube with ENFit connectors
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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?
38561 Nasogastric/orogastric tube
A sterile, hollow cylinder that can be introduced into the gastrointestinal (GI) tract both nasally and orally for feeding and/or aspiration. It is made of plastic or rubber and is available in a variety of designs and lengths. Some types are a simple rubber tube with a glass window; other types can be radiopaque to assist accurate placement, have multiple flow-through eyes, and dual connectors (e.g., one for suction and the other for irrigation/feeding). Other uses can be to decompress the stomach, withdraw specimens for diagnostic analysis, administer medications, and for irrigation of the stomach to treat upper gastrointestinal (UGI) bleeding. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FPD Tube, Feeding
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K100526 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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

c8e0d4b0-a6b6-474f-9717-5070b63e6848
July 06, 2018
3
August 12, 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
30817522012388 200 10817522012384 In Commercial Distribution case
20817522012381 10 10817522012384 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: 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

[?]
949-863-0810
kjrooks@kentecmedical.com
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