Home GUDID 00850070979375 FondCircle
Primary DI 00850070979375
Brand FondCircle
Company FondCircle Inc.
Model FBG-M2
Published 2026-10-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name NBW System, Test, Blood Glucose, Over The Counter QRL Multiple Use Blood Lancet For Single Patient Use Only
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2 QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850070979375 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850070979375 00850070979375 850070979375 0850070979375
GMDN Terms# Term, Definition table Term Definition Manual blood lancing device, single-use A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.
Regulatory Flags# DUNS number 060715854 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850070979320 FondCircle FondCircle Inc. QRL 2026-10-26 00850070979337 FondCircle FondCircle Inc. QRL 2026-10-26 00850070979344 FondCircle FondCircle Inc. NBW 2026-10-26 00850070979351 FondCircle FondCircle Inc. NBW 2026-10-26 00850070979368 FondCircle FondCircle Inc. NBW 2026-10-26 04719869706966 medisana BG 150 Blood Glucose Meter TYSON BIORESEARCH INC. NBW 2026-08-19 04719869707000 BG 150 Control Solution TYSON BIORESEARCH INC. NBW 2026-08-19 04719869707017 BG 150 Control Solution TYSON BIORESEARCH INC. NBW 2026-08-19 04719869707024 BG 150 Blood Glucose Test Strip(50T) TYSON BIORESEARCH INC. NBW 2026-08-19 00050428167298 TRUEdraw TRIVIDIA HEALTH, INC. QRL 2026-08-14 00384841518802 Prodigy AutoCode Blood Glucose Monitoring System Prodigy Diabetes Care, LLC NBW 2026-08-13 00682607551354 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551361 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551378 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815234 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815241 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815258 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815265 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551385 ON CALL® SURE BLOOD CONTROL SOLUTION Acon Laboratories, Inc. NBW 2026-07-30 00682607551392 ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607551408 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551422 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551439 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551446 ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607551453 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551460 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551477 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607815098 ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607815104 ON CALL® SURE GK BLOOD GLUCOSE & KETONE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607815111 ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30