Home GUDID 00853041003239 3B Medical, Inc
Primary DI 00853041003239
Brand 3B Medical, Inc
Company 3b Medical, Inc.
Model RO5010
Device description 3B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasal Pillow System size SMALL
Published 2016-08-18
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name BZD Ventilator, Non-Continuous (Respirator)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BZD Ventilator, Non-Continuous (Respirator) Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00853041003239 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 00853041003239 00853041003239 853041003239 0853041003239
GMDN Terms# Term, Definition table Term Definition CPAP/BPAP nasal mask, reusable A flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.
Regulatory Flags# DUNS number 078517316 Device count 1 Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00853041003000 3B Medical Aer Aer X 021000M 2019-08-13 00853041003048 3B Medical, Inc. EO2001 2016-09-06 00853041003079 3B medical, inc. RO3001 2016-08-18 00853041003086 3B Medical, Inc. RO3002 2016-08-18 00853041003093 3B Medical, Inc. RO3003 2016-08-18 00853041003222 3B Medical, Inc. RO1000 2016-08-18 00853041003246 3B Medical, Inc. RO5020 2016-08-18 00853041003253 3B Medical, Inc. RO1001 2016-08-19 00853041003260 3B Medical, Inc. RO1002 2016-08-18 00853041003277 3B Medical, Inc. RO1003 2016-08-18 00853041003369 3B Medical, Inc. RO5030 2016-08-18 00853041003543 3B Medical, Inc. RO2001 2016-08-18 00853041003611 3B Medical, Inc. ELA1003 2016-09-07 00853041003628 3B Medical, Inc. ELA6010 2016-09-06 00853041003635 3B Medical, Inc. ELA6020 2016-09-07 00853041003642 3B Medical, Inc. ELA6030 2016-09-06 00853041003703 3B Medical, Inc.'s Cirrus 5 CIR1005 2016-08-18 00853041003796 3B Medical, Inc. CIR5550 2016-08-19 00853041003802 3B Medical, Inc. AE2001 2016-08-19 00853041003819 3B Medical, Inc CIR1020 CIR1030 2016-08-18
Other Devices Sharing Product Codes#