Data / Medical devices / United States / Nurse Assist, LLC
Nurse Assist, LLC: FDA-registered device maker in Haltom City, TX, United States, 13 510(k) clearances
Nurse Assist, LLC is registered with the FDA (registration 1650927) in Haltom City, TX, United States. It lists 10 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 11, 2020. 4 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1650927
- FEI number
- 3002695476
- Address
- 4409 Haltom Rd, Haltom City, TX, United States, 76117
- Owner or operator
- Nurse Assist, LLC (10058083)
- Roles
- Manufacturer
- First device listed
- July 5, 2018
- Registered through
- 2026
- Brand names listed
- 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, BD 140061-01 0.9% SALINE IRRIGATION BOTTLE 100 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, BD 140065-01 0.9% SALINE IRRIGATION BOTTLE 500 ML, BD 140066-01 STERILE WATER IRRIGATION BOTTLE 500 ML, BD 140067-01 0.9% SALINE IRRIGATION BOTTLE 1000 ML and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Bed Patient | KMI | 1 | Manufacturer | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2020 | K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch | NGT | Substantially Equivalent | Nurse Assist, LLC | accessdata.fda.gov |
| August 31, 2015 | K150143 | Normal Saline Flush | NGT | Substantially Equivalent | Nurse Assist, Inc. | accessdata.fda.gov |
| August 10, 2012 | K121390 | LUBE JELLY SURINGE | KMJ | Substantially Equivalent | Nurse Assist, Inc. | accessdata.fda.gov |
| December 18, 2008 | K083042 | WOUND FLUSH, STERILE WATER & NORMAL SALINE | FRO | Substantially Equivalent | Nurse Assist, Inc. | accessdata.fda.gov |
| May 30, 2003 | K030813 | PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND | EZL | Substantially Equivalent | Primary Care Solutions, Inc. | accessdata.fda.gov |
| May 23, 1994 | K942194 | QUANTUM BI-POLAR ELECTROSURGICAL CABLE | GEI | Substantially Equivalent | Quantum Instruments Corp. | accessdata.fda.gov |
| May 23, 1994 | K941908 | QUANTUM MONO-POLAR ELECTROSURGICAL CABLE | GEI | Substantially Equivalent | Quantum Instruments Corp. | accessdata.fda.gov |
| April 1, 1991 | K905586 | RSVP RF-2000 | KMI | Substantially Equivalent | Tactilitics, Inc. | accessdata.fda.gov |
| November 29, 1990 | K904158 | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY | FCM | Unknown | Welcon, Inc. | accessdata.fda.gov |
| January 21, 1987 | K864827 | RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR | KMI | Substantially Equivalent | Tactilitics, Inc. | accessdata.fda.gov |
| February 12, 1985 | K842166 | INTERMED, INS STERILE WATER/SALINE | BSY | Substantially Equivalent | Intermed, Inc. | accessdata.fda.gov |
| March 17, 1983 | K830359 | STERILE CATHERIZATION PROCEDURE TRAYS | KOD | Substantially Equivalent | Welcon, Inc. | accessdata.fda.gov |
| November 20, 1981 | K813027 | STERILE IRRIGATING SYRINGES, KITS,TRAY | KYZ | Substantially Equivalent | Welcon, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 6, 2023 | 93434 | Class I | Ongoing | 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. | accessdata.fda.gov |
| October 4, 2016 | 75348 | Class I | Terminated | Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush | Potential contamination with B. cepacia. | accessdata.fda.gov |
| September 2, 2011 | 60412 | Not yet classified | Terminated | McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 | Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. | accessdata.fda.gov |
| January 20, 2011 | 58021 | Not yet classified | Terminated | Case Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-103 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 | The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Retention Type, Balloon
- All makers of Dressing, Wound, Drug
- All makers of Monitor, Bed Patient
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Lubricant, Patient
Updated December 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.