IS60ENO-ENF

GUDID 20816336022609

Enteral Tubing Enteral Only 60" (ISO 80369-3 Compatible)

NEOCHILD, LLC

Nasogastric feeding tube
Primary Device ID20816336022609
NIH Device Record Key4e2764e7-1d28-4bf9-9681-9f84b02874e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameIS60ENO-ENF
Version Model NumberIS60ENO-ENF
Company DUNS022760922
Company NameNEOCHILD, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110816336022602 [Primary]
GS120816336022609 [Package]
Contains: 10816336022602
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


[20816336022609]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-15
Device Publish Date2023-05-05

Devices Manufactured by NEOCHILD, LLC

10816336020936 - NC40100T2024-12-23 Lumbar Puncture Tray w/ 22ga, 1" Needle
20816336020971 - KMI-UACTRAYH2024-07-23
02081633602005 - IS60ENOC2024-06-20 Enteral Only Tubing 60" with Step Connector Cap
20816336022739 - NC23000T2024-04-01 Catheterization Tray
20816336022388 - NC1P65SE-ENF2024-01-19 Feeding Tube 6.5 Fr. x 40 cm. - Polyurethane (ISO 80369-3 Compatible)
20816336022203 - NC600500-ENF2023-12-27 Enteral Only 5mL Syringe with Oral Cap (ISO 80369-3 Compatible)
20816336022678 - NC603000-ENF2023-12-27 Enteral Only 30mL Syringe with Oral Cap (ISO 80369-3 Compatible)
20816336022784 - NC601000-ENF2023-12-27 Enteral Only 10mL Syringe with Oral Cap (ISO 8036-3 Compatible)

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