FDA.reportPublic FDA data

Numa Full Face Mask

Primary DI
06948538360293
Brand
Numa Full Face Mask
Company
BMC Medical Co., Ltd.
Model
Size:Small
Device description
Numa Full Face Mask
Published
2017-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163464000Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.2017-09-05BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16948538360290PackageGS115In Commercial Distribution
06948538360293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694853836029016948538360290
06948538360293069485383602936948538360293

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, reusableA flexible, form-shaped device designed to be placed over a user's nose and mouth 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 and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
526010310
Device count
1
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
09420012464668Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
09420012423573Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
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09420012448446Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448514Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
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09420012456434Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464644Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464682Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
04719893347272WellellWellell Inc.BZD2026-03-17
09420012461629F&P ViteraFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-01-27
09420012472212NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472229NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472236NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472243NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472366NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472373NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472380NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472397NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
08056814676223DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676247DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676254DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676261DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676377DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676384DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676391DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676407DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676230DIMARHMC PREMEDICAL SPABZD2025-03-20