Lightning X Products, Inc

GUDID 16946430413663

Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg, Child: less than or equal to 23 Kg, Adult: greater than 23 Kg

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use
Primary Device ID16946430413663
NIH Device Record Key9daa4659-a6ad-4aad-bc4e-bd2eb01c454c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightning X Products, Inc
Version Model NumberNPVC-001/RTMA
Company DUNS543482946
Company NameXIAMEN COMPOWER MEDICAL TECH. CO., LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106946430413666 [Primary]
GS116946430413663 [Package]
Contains: 06946430413666
Package: carton [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-30

Devices Manufactured by XIAMEN COMPOWER MEDICAL TECH. CO., LTD

06946430401618 - Aquatic Solutions2024-04-03 Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, two pieces alcohol pa
16946430401806 - Ever Ready First Aid2024-04-03 Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, two pieces alcohol pa
16946430414844 - Inkwell Global Marketing2024-04-03 Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, two pieces alcohol pa
16946430416107 - FIRST AID ONLY2023-11-27 Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, two pieces alcohol pads and one pair Nitril glove. CPR Mas
16946430415827 - NAUI2023-08-30 CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emerg
16946430415681 - Typenex2023-08-14 Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air
16946430415698 - Typenex2023-08-14 Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air
16946430415704 - Typenex2023-08-14 Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air
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