FDA.reportPublic FDA data

IVWATCH, LLC

Matched from indexed company URL: IvWatch, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30114900913011490091IVWATCH, LLC1N2026-01-01700 Tech Center Parkway, Suite 300 Newport News VA US 23606

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00814088020009ivWatch Patient Monitor - A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events757-705-2461chuck.egress@ivwatch.com
00814088020115ivWatch Patient Cable - Reusable, Electronic Patient Cable757-705-2461chuck.egress@ivwatch.com
00814088020122ivWatch Extension Module - A device accessory for the ivWatch Model 400 that provides support for the ivWatch SmartTouch Sensor757-705-2461chuck.egress@ivwatch.com
00814088020382ivWatch Patient Monitor - ivWatch Patient Monitor, Model 400, English, Lease757-705-2461chuck.egress@ivwatch.com
00814088020726blox - Surgical N95 Respirator(855) 489-2824technicalsupport@ivwatch.com
00814088020788blox - Surgical N95 Respirator(855) 489-2824technicalsupport@ivwatch.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1807461367820619K233881ivWatch® Model 400PMS2024-03-15
1807461282977588K222212ivWatch Model 400PMS2022-08-24
1807461532516258K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CablePMS2020-07-02
1807461019131580K162478ivWatchPMS2016-12-22
1807461753269902K153605ivWatch Model 400PMS2016-02-11
1807461993213598K142374ivWatch Model 400MRZ2015-02-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PMS52024-03-15
MRZ12015-02-13

PMN#

GUDID#