FDA.reportPublic FDA data

NA

Primary DI
06948538360415
Brand
NA
Company
BMC Medical Co., Ltd.
Model
F2 NV2(Large)
Device description
F2 Single-Patient Non-Vented Full Face Mask
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16948538360412PackageGS115In Commercial Distribution
06948538360415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694853836041216948538360412
06948538360415069485383604156948538360415

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1-863-226-6285cpewitt@3Bproducts.com

Regulatory Flags#

DUNS number
526010310
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948538340165Siesta Contour Nasal MaskN5A+ (Small)2026-02-02
06948538340172Siesta Contour Nasal MaskN5A+ (Medium)2026-02-02
06948538340189Siesta Contour Nasal MaskN5A+ (Large)2026-02-02
06948538340196Siesta Contour Nasal MaskN5A+ (Extra Large)2026-02-02
06948538340202Siesta Contour Nasal MaskN5A+ (All Size Kit)2026-02-02
06948538340219Siesta Contour Nasal MaskN5A+ (All Size Kit)-Sample2026-02-02
06948538340226Siesta Contour Nasal MaskN5A+ (Small)-Sleep Lab2026-02-02
06948538340233Siesta Contour Nasal MaskN5A+ (Medium)-Sleep Lab2026-02-02
06948538340240Siesta Contour Nasal MaskN5A+ (Large)-Sleep Lab2026-02-02
06948538340257Siesta Contour Nasal MaskN5A+ (Extra Large)-Sleep Lab2026-02-02
06948538340264Siesta Contour Nasal MaskN5A+ (All Size Kit)-Sleep Lab2026-02-02
16948538340162Siesta Contour Nasal MaskN5A+ (Small)2026-02-02
16948538340179Siesta Contour Nasal MaskN5A+ (Medium)2026-02-02
16948538340186Siesta Contour Nasal MaskN5A+ (Large)2026-02-02
16948538340193Siesta Contour Nasal MaskN5A+ (Extra Large)2026-02-02
16948538340209Siesta Contour Nasal MaskN5A+ (All Size Kit)2026-02-02
16948538340216Siesta Contour Nasal MaskN5A+ (All Size Kit)-Sample2026-02-02
16948538340223Siesta Contour Nasal MaskN5A+ (Small)-Sleep Lab2026-02-02
16948538340230Siesta Contour Nasal MaskN5A+ (Medium)-Sleep Lab2026-02-02
16948538340247Siesta Contour Nasal MaskN5A+ (Large)-Sleep Lab2026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919008Salter Labs® Adult Comfort Face TentSALTER LABSBYG2026-06-09
00607411919053Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14