Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1650927

FEI Number

3002695476

Entity Name

NURSE ASSIST, LLC

City/State/Country

Haltom City, TX, US

Establishment Address

4409 Haltom Rd, Haltom City, TX 76117, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nurse Assist, LLC (Owner Number: 10058083)

Owner / Operator Contact Address

4409 Haltom Rd., Haltom City, TX 76117, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030813

PMA Number

N/A

All Registered Proprietary Names

RN+ Monitor 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery Quantum Monopolar Electrosurgical Cable Nurse Assist Nurse Assist Quantum Bipolar Electrosurgical Cable Nurse Assist Nurse Assist BD 140068-01 STERILE WATER IRRIGATION BOTTLE 1000 ML BD 140066-01 STERILE WATER IRRIGATION BOTTLE 500 ML Nurse Assist BD 140061-01 0.9% SALINE IRRIGATION BOTTLE 100 ML BD 140065-01 0.9% SALINE IRRIGATION BOTTLE 500 ML BD 140067-01 0.9% SALINE IRRIGATION BOTTLE 1000 ML BD 140062-01 STERILE WATER IRRIGATION BOTTLE 100 ML BD 140063-01 0.9% SALINE IRRIGATION BOTTLE 250ML BD 140064-01 STERILE WATER IRRIGATION BOTTLE 250ML Nurse Assist

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2018-07-05
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2020-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-07-05
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-07-05
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2018-07-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-07-05
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2018-07-05
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2018-07-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-07-05
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2018-07-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nurse Assist, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1650927. Last updated year: 2026. Please use registration number 1650927 when referencing this establishment in official correspondence.