FDA.reportPublic FDA data

3B Medical, Inc.

Primary DI
00853041003260
Brand
3B Medical, Inc.
Company
3b Medical, Inc.
Model
RO1002
Device description
3B Medical, Inc Rio Nasal Pillow mask Mediumincludes a mask, headgear and a medium nasal pillow cushion
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
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853041003260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853041003260008530410032608530410032600853041003260

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078517316
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008530410030003B Medical AerAer X021000M2019-08-13
008530410030483B Medical, Inc.EO20012016-09-06
008530410030793B medical, inc.RO30012016-08-18
008530410030863B Medical, Inc.RO30022016-08-18
008530410030933B Medical, Inc.RO30032016-08-18
008530410032223B Medical, Inc.RO10002016-08-18
008530410032393B Medical, IncRO50102016-08-18
008530410032463B Medical, Inc.RO50202016-08-18
008530410032533B Medical, Inc.RO10012016-08-19
008530410032773B Medical, Inc.RO10032016-08-18
008530410033693B Medical, Inc.RO50302016-08-18
008530410035433B Medical, Inc.RO20012016-08-18
008530410036113B Medical, Inc.ELA10032016-09-07
008530410036283B Medical, Inc.ELA60102016-09-06
008530410036353B Medical, Inc.ELA60202016-09-07
008530410036423B Medical, Inc.ELA60302016-09-06
008530410037033B Medical, Inc.'s Cirrus 5 CIR10052016-08-18
008530410037963B Medical, Inc.CIR55502016-08-19
008530410038023B Medical, Inc.AE20012016-08-19
008530410038193B Medical, IncCIR1020 CIR10302016-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344011858HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011865HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011872HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011889HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011896HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011902HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011919HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011926HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011933HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011940HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011957HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011964HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
00848530109677CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00848530109684CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00198843003606Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003613Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003620Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003637Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003644Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003651Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003668Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003675Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003682Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003699Infant Flow™Zoll Medical CorporationBZD2026-08-14
06970819423212RXiBreeze PAP SystemResvent Medical Technology Co., Ltd.BZD2026-08-14
00850088881097MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881103MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881035IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14