Hypothermia Devices Inc

FDA Filings

This page includes the latest FDA filings for Hypothermia Devices Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015252349
• FEI Number: 3015252349
• Name: Kelvi
• Owner & Operator: Hypothermia Devices, Inc. (dba Kelvi)
• Contact Address: 413 N Oak Street ; Inglewood CA 90302 US
• Official Correspondent:
  • Julio L Vergara
  • x-310-9234749-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 413 N Oak Street ; Inglewood, CA 90302 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00850001185110 HYPOTHERMIA DEVICES, INC.	Kelvi	2024-01-24
GUDID 00850001185103 HYPOTHERMIA DEVICES, INC.	Kelvi	2024-01-24
GUDID 00850001185073 HYPOTHERMIA DEVICES, INC.	Kelvi	2023-12-18
GUDID 00850001185059 HYPOTHERMIA DEVICES, INC.	Kelvi	2019-06-25
GUDID 00850001185042 HYPOTHERMIA DEVICES, INC.	Kelvi	2019-06-25
GUDID 00850001185035 HYPOTHERMIA DEVICES, INC.	Kelvi	2019-06-25
GUDID 00850001185028 HYPOTHERMIA DEVICES, INC.	Kelvi	2019-06-25
GUDID 00850001185011 HYPOTHERMIA DEVICES, INC.	Kelvi	2019-06-25
GUDID 00850001185004 HYPOTHERMIA DEVICES, INC.	Kelvi	2019-06-25
ILO Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]	Kelvi Shoulder Pro Smart Wrap	2018-07-10
ILO Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]	Kelvi Pro Umbilical	2018-07-10
ILO Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]	Kelvi Pro Console	2018-07-10
ILO Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]	Kelvi Knee Pro Smart Wrap	2018-07-10
ILO Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]	Kelvi Hand Station	2018-07-10
ILO Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]	Kelvi Back Pro Smart Wrap	2018-07-10
ILO Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]	Kelvi Ankle Pro Smart Wrap	2018-07-10

Related Finance Registrations

NCAGE Code	75D70	HYPOTHERMIA DEVICES, INC.!DBA KELVI
CAGE Code	75D70	HYPOTHERMIA DEVICES, INC. KELVI
S.A.M. Registration	75D70 [79330735]	HYPOTHERMIA DEVICES, INC. KELVI
SEC	0001758185	Hypothermia Devices, Inc. of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019062650922	Yantian,China (Mainland) -> Los Angeles, California	EVA CASES	132 CTN