NC30350T

GUDID 10816336020981

3.5 Fr. Silicone Urinary Collection Kit with catheter

NEOCHILD, LLC

Urethral catheterization support kit, urinary drainage
Primary Device ID10816336020981
NIH Device Record Key8ab92d43-b61d-440b-ae11-e374dd9b0a22
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC30350T
Version Model NumberNC30350T
Company DUNS022760922
Company NameNEOCHILD, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110816336020356 [Primary]
GS110816336020981 [Package]
Contains: 10816336020356
Package: [5 Units]
In Commercial Distribution

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-09
Device Publish Date2018-02-19

Devices Manufactured by NEOCHILD, LLC

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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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