FDA.reportPublic FDA data

AC/DC Power Adapter

Primary DI
06948538362648
Brand
AC/DC Power Adapter
Company
BMC Medical Co., Ltd.
Model
AD-NJ
Device description
AC/DC Power Adapter
Published
2022-08-29
Public version status
Update
Distribution status
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
16948538362645PackageGS130In Commercial Distribution
06948538362648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694853836264516948538362645
06948538362648069485383626486948538362648

GMDN Terms#

Term, Definition table
TermDefinition
Home CPAP unitA portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.

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
06948538362563Water ChamberWT-C12022-08-29
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

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Primary DI, Brand, Company table
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