FDA.reportPublic FDA data

EMI

Primary DI
06946430414366
Brand
EMI
Company
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Model
CP641000+2A+PG
Device description
The cardiopulmonary resuscitation aid kit comprises of one CPR mask with Oxygen Port, two pieces alcohol pads and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing patient. It functions as a barrier to direct expired air from the patient away from the user. It can be used with supplemental oxygen when needed.
Published
2022-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEVCardiopulmonary Resuscitation Aid Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEVCardiopulmonary Resuscitation Aid KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16946430414363PackageGS160In Commercial Distribution
06946430414366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694643041436316946430414363
06946430414366069464304143666946430414366

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation kit, single-useA collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a single-use device.

Regulatory Flags#

DUNS number
543482946
Device count
1
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
10194717121022Regard™ROI CPS, LLCOEV2025-02-18
10889483166291SuperNO2VAAIRLIFEOEV2025-02-14
10889483166307SuperNO2VAAIRLIFEOEV2025-02-14
10889483606025SuperNO2VAAIRLIFEOEV2025-02-14
10889483606049SuperNO2VAAIRLIFEOEV2025-02-14
10194717121039Regard™ROI CPS, LLCOEV2025-02-13
10194717121046Regard™ROI CPS, LLCOEV2025-02-13
10194717121053Regard™ROI CPS, LLCOEV2025-02-13
10194717121060Regard™ROI CPS, LLCOEV2025-02-13
10194717120971Regard™ROI CPS, LLCOEV2025-02-10
10194717120988Regard™ROI CPS, LLCOEV2025-02-10
10194717120216Regard™ROI CPS, LLCOEV2024-10-31
10194717120223Regard™ROI CPS, LLCOEV2024-10-31
10194717120254Regard™ROI CPS, LLCOEV2024-10-31
10194717120261Regard™ROI CPS, LLCOEV2024-10-31
10194717120278Regard™ROI CPS, LLCOEV2024-10-31
10194717120230Regard™ROI CPS, LLCOEV2024-10-30
10194717120247Regard™ROI CPS, LLCOEV2024-10-30
10194717120285Regard™ROI CPS, LLCOEV2024-10-30
10194717120186Regard™ROI CPS, LLCOEV2024-10-21
10194717120193Regard™ROI CPS, LLCOEV2024-10-21
10194717120209Regard™ROI CPS, LLCOEV2024-10-21
10194717120001Regard™ROI CPS, LLCOEV2024-10-02
10194717120049Regard™ROI CPS, LLCOEV2024-09-27
10194717119883Regard™ROI CPS, LLCOEV2024-08-01
10194717119876Regard™ROI CPS, LLCOEV2024-07-15
10194717119838Regard™ROI CPS, LLCOEV2024-07-05
10194717119845Regard™ROI CPS, LLCOEV2024-07-05
10194717119777Regard™ROI CPS, LLCOEV2024-06-25
10194717119784Regard™ROI CPS, LLCOEV2024-06-25