FDA.reportPublic FDA data

3B Medical, Inc.

Primary DI
00853041003611
Brand
3B Medical, Inc.
Company
3b Medical, Inc.
Model
ELA1003
Device description
3B Medical's LARGE Elara full face mask, comes complete with mask frame, cushion and headgear
Published
2016-09-07
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
00853041003611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853041003611008530410036118530410036110853041003611

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
Manufacturing date on label
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
008530410032603B Medical, Inc.RO10022016-08-18
008530410032773B Medical, Inc.RO10032016-08-18
008530410033693B Medical, Inc.RO50302016-08-18
008530410035433B Medical, Inc.RO20012016-08-18
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
00848530106461CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106478CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106485CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106492CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106508CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106515CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-17
00848530106355CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106362Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106379CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106386CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106393CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106409Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
10889483586358Vital Signs™AIRLIFEBZD2025-02-18
00848530081638CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
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00848530097134CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
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00848530097158CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29