Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004167615

FEI Number

3004167615

Entity Name

MFG ONE, LLC

City/State/Country

CHANTILLY, VA, US

Establishment Address

14851 Stonecroft Center Ct, CHANTILLY, VA 20151, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MFG ONE, LLC (Owner Number: 9058759)

Owner / Operator Contact Address

3900 SKYHAWK DR., --, Chantilly, VA 20151, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Temp 2 - 5000 Series Temp 2 - 6000 Series Temp 2 8N1 16N1 HEAT STACK T HOLD OpClear System IntraTemp Fluid Warming System Hush - Slush Irrigation Warmer - 2000 Series IntraTemp Fluid Warming System - ITW6L Smart Warmer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2007-12-14
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2007-12-14
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2005-12-01
LDQ	N/A	N/A	Class N/A	N/A	2005-12-01
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-12-15
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-12-15
LHC	Warmer, Irrigation Solution	Physical Medicine	Class 1	890.5950	2020-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MFG ONE, 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
K891023	Siemens Medical Electronics	SIEMENS CEILING STAND 800F, 800 AND 810	1989-07-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Similar Registrations

Registration Number	Establishment Name	Location
3003018304	ECM EUROPE BV	Gemert Noord-Brabant, NL
3006715577	A/S KURT HANSEN	Svendborg Syddanmark, DK
9614609	PROVITA Medical GmbH & Co. KG	WERMELSKIRCHEN North Rhine-Westphalia, DE
3010317211	TRIBALCO	Tampa, FL, US
3012302888	QUIPMENT INC.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004167615. Last updated year: 2026. Please use registration number 3004167615 when referencing this establishment in official correspondence.