FDA.reportPublic FDA data

compower

Primary DI
06946430401014
Brand
compower
Company
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Model
CP650033
Device description
Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air and/or oxygen. The mask is a Non-Sterile Product for single patient use.
Published
2018-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16946430401011PackageGS1150In Commercial Distribution
06946430401014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694643040101116946430401011
06946430401014069464304010146946430401014

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

Regulatory Flags#

DUNS number
543482946
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946430426185GFACP6410072026-06-01
06946430414373EMICP6460032022-11-15
06946430400192CompowerCP6410002017-12-31
06946430425683WNL Products CP641000+1A+NG2026-03-01
06946430425690WNL Products CP641000+1A+NG2026-03-01
06946430425706WNL Products CP641000+CP641007+1A+NG2026-03-01
06946430425713WNL Products CP641000+CP641007+1A+NG2026-03-01
16946430425680WNL Products CP641000+1A+NG2026-03-01
16946430425697WNL Products CP641000+1A+NG2026-03-01
16946430425703WNL Products CP641000+CP641007+1A+NG2026-03-01
16946430425710WNL Products CP641000+CP641007+1A+NG2026-03-01
06946430410832CompowerNPVC-001/RTMA2021-09-15
06946430425072Lightning X Products, IncCOL0072025-12-24
06946430425201CompowerS402025-12-24
06946430425218CompowerS502025-12-24
06946430425225CompowerS602025-12-24
06946430425232CompowerS702025-12-24
06946430425249CompowerS802025-12-24
06946430425256CompowerS902025-12-24
06946430425263CompowerS1002025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071405CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-04-06
10192253071412CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071429CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071436CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071443CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071450CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071467CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10197344137435MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-03-05
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10197344131693MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10197344131723MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10612479274218McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274232McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274256McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274270McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274294McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10197344131679MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131686MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
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10197344103706MEDLINEMEDLINE INDUSTRIES, INC.BSJ2024-06-10
10193489135367MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10193489135374MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10193489135381MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10197344097180MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097197MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097203MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097210MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097227MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097234MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23