Telcare L L C

FDA Filings

This page includes the latest FDA filings for Telcare L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008514395
• FEI Number: 3008514395
• Name: Telcare, LLC
• Owner & Operator: Telcare, LLC
• Contact Address: 150 Baker Avenue Extension, Suite 300 ; Concord MA 01742 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 150 Baker Avenue Ext Ste 300 ; Concord, MA 01742 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 00859519002391 TELCARE, LLC	BioTel Care BGM 4 TM0009	2021-01-25
GUDID 10859519002053 TELCARE, LLC	BioTel Care® Double Control Solution TC0003	2019-03-19
GUDID 00859519002261 TELCARE, LLC	BioTel Care® Test Strips TT0003	2019-03-19
GUDID 00859519002247 TELCARE, LLC	Telserve® Data Management System	2019-03-19
GUDID 00859519002223 TELCARE, LLC	BioTel Care® Blood Glucose Monitoring System TM0008	2019-03-19
PMN K110571 | NBW Telcare, LLC	Telcare	2012-02-03
PMN K110571 | NBW Telcare, LLC	Telcare Cloud	2012-02-03
PMN K110571 | NBW Telcare, LLC	Telcare Blood Glucose Monitoring System	2012-02-03
PMN K110571 | NBW Telcare, LLC	Telcare BGM	2012-02-03
PMN K110571 | NBW Telcare, LLC	BioTel Care? Blood Glucose Monitoring System	2012-02-03
PMN K110571 | NBW Telcare, LLC	BioTel Care? BGM	2012-02-03
PMN K110571 | JQP Telcare, LLC	Telcare	2012-02-03
PMN K110571 | JQP Telcare, LLC	Telcare Cloud	2012-02-03
PMN K110571 | JQP Telcare, LLC	Telcare Blood Glucose Monitoring System	2012-02-03
PMN K110571 | JQP Telcare, LLC	Telcare BGM	2012-02-03
PMN K110571 | JQP Telcare, LLC	BioTel Care? Blood Glucose Monitoring System	2012-02-03
PMN K110571 | JQP Telcare, LLC	BioTel Care? BGM	2012-02-03
PMN K110571 | JJX Telcare, LLC	Telcare	2012-02-03
PMN K110571 | JJX Telcare, LLC	Telcare Cloud	2012-02-03
PMN K110571 | JJX Telcare, LLC	Telcare Blood Glucose Monitoring System	2012-02-03
PMN K110571 | JJX Telcare, LLC	Telcare BGM	2012-02-03
PMN K110571 | JJX Telcare, LLC	BioTel Care? Blood Glucose Monitoring System	2012-02-03
PMN K110571 | JJX Telcare, LLC	BioTel Care? BGM	2012-02-03
PMN K110571 | CGA Telcare, LLC	Telcare	2012-02-03
PMN K110571 | CGA Telcare, LLC	Telcare Cloud	2012-02-03
PMN K110571 | CGA Telcare, LLC	Telcare Blood Glucose Monitoring System	2012-02-03
PMN K110571 | CGA Telcare, LLC	Telcare BGM	2012-02-03
PMN K110571 | CGA Telcare, LLC	BioTel Care? Blood Glucose Monitoring System	2012-02-03
PMN K110571 | CGA Telcare, LLC	BioTel Care? BGM	2012-02-03

Related Finance Registrations

NCAGE Code	5DBZ3	TELCARE LLC
CAGE Code	5DBZ3	TELCARE LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202007257295	Pusan,South Korea -> Boston, Massachusetts	BIOTEL CARE METER(TM0008) HTS CODE:9027.80.453 6 PALLETS = 267 CTNS SET TEMPERATURE : +15.0 C	267 CTN
202005143898	Pusan,South Korea -> Boston, Massachusetts	BIOTEL CARE METER(TM0008) HTS CODE:9027.80.453 9 PLTS = 382 CTNS SET TEMPERATURE : +15.0 C	382 CTN
202004172083	Pusan,South Korea -> Boston, Massachusetts	BIOTEL CARE METER(TM0008), HTS CODE:9027.80.453 11 PLTS = 431 CTNS SET TEMPERATURE : +15.0 C	431 CTN
202004162579	Pusan,South Korea -> Boston, Massachusetts	BIOTEL CARE METER(TM0008), HTS CODE:9027.80.453 11 PLTS = 431 CTNS SET TEMPERATURE : +15.0 C	431 CTN
202002283688	Pusan,South Korea -> Boston, Massachusetts	BIOTEL CARE METER(TM0008), TELCARE TEST STRIP (50 CT) FOR G 2.0(TT0003) HTS CODE:3822.00.1090,9027.80.453 15 PLTS = 678 CTNS SET TEMPERATURE : +15.0 C	678 CTN
202002283726	Pusan,South Korea -> Boston, Massachusetts	BIOTEL CARE METER(TM0008), TELCARE TEST STRIP (50 CT) FOR G 2.0(TT0003) HTS CODE:3822.00.1090,9027.80.453 15 PLTS = 678 CTNS SET TEMPERATURE : +15.0 C	678 CTN
201911212805	Ningpo ,China (Mainland) -> Boston, Massachusetts	TELCARE TEST STRIP (50 CT) FOR G 2.0(TT0003) HTS CODE:3822.00.1090 4 PLTS = 210 CTNS SET TEMPERATURE : +15.0 C	210 CTN
201910242111	Ningpo ,China (Mainland) -> Boston, Massachusetts	TELCARE TEST STRIP (50 CT) FOR G 2.0(TT0003) HTS CODE:3822.00.1090 9 PLTS = 421 CTNS SET TEMPERATURE : +15.0 C	421 CTN