Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1057300

FEI Number

1000151124

Entity Name

Aquabiliti

City/State/Country

NASHVILLE, TN, US

Establishment Address

5209 Linbar Dr Ste 640, NASHVILLE, TN 37211, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

MRP, LLC (Owner Number: 9076844)

Owner / Operator Contact Address

5209 Linbar Drive, Suite 640, Nashville, TN 37211, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133685

PMA Number

N/A

All Registered Proprietary Names

AMUSA Flush Syringe / Aquastat Saline Flush AquastatSFR 10mL Sterile Saline flush AquastatSFR 20mL Sterile Saline flush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2014-05-22
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2014-05-22
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2020-07-14

Official Correspondent

Dipen Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MRP, LLC

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

View Entity Profile →

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.

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3016413378	JIAXING TIANHE PHARMACEUTICAL CO., LTD.	Jiaxing Zhejiang, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1057300. Last updated year: 2026. Please use registration number 1057300 when referencing this establishment in official correspondence.