Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011490091

FEI Number

3011490091

Entity Name

IVWATCH, LLC

City/State/Country

Newport News, VA, US

Establishment Address

700 Tech Center Parkway, Suite 300, Newport News, VA 23606, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ivWatch, LLC (Owner Number: 10048801)

Owner / Operator Contact Address

700 Tech Center Parkway, Suite 300, Newport News, VA 23606, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162478

PMA Number

N/A

All Registered Proprietary Names

ivWatch Model 400 ivWatch Model 400 ivWatch Model 400 ivWatch Model 400 ivWatch Model 400

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2015-03-03
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	General Hospital	Class 2	880.5725	2022-08-26
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	General Hospital	Class 2	880.5725	2016-07-14
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	General Hospital	Class 2	880.5725	2020-07-14
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	General Hospital	Class 2	880.5725	2017-01-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ivWatch, LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011490091. Last updated year: 2026. Please use registration number 3011490091 when referencing this establishment in official correspondence.