Compower

GUDID 16946430410853

The inteneded use for Child Disposable Manual Resuscitator: 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. It is for child population. It is disposable.

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 16946430410853
• NIH Device Record Key: 5bf655e3-72a1-47bb-9a6e-e5dd30478338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compower
• Version Model Number: NPVC-002/RTMA
• Company DUNS: 543482946
• Company Name: XIAMEN COMPOWER MEDICAL TECH. CO., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06946430410856 [Primary]
GS1	16946430410853 [Package]; Contains: 06946430410856; Package: carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210288

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-23
• Device Publish Date: 2021-09-15

On-Brand Devices [Compower]

• 06946430499882: Disposable Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, ane
• 16946430401042: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia mas
• 16946430401035: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia mas
• 06946430401021: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia mas
• 16946430401011: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia mas
• 16946430400595: Cardiopulmonary resuscitation kit contains CPR Mask without Oxygen Port, Infant CPR Mask without
• 06946430400574: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Ox
• 16946430400564: The cardiopulmonary resuscitation aid kit comprised of one CPR Mask without Oxygen Port, one Inf
• 16946430400540: The cardiopulmonary resuscitation aid kit comprised of one CPR Mask with Oxygen Port, one Infant
• 16946430400533: Cardiopulmonary resuscitation kit contains CPR Mask without Oxygen Port and Infant CPR Mask with
• 16946430400496: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port and Infant CPR Mask without
• 16946430400489: Cardiopulmonary resuscitation kit contains Infant CPR Mask without Oxygen Port, two pieces alcoh
• 16946430400458: Cardiopulmonary resuscitation kit contains CPR Mask without Oxygen Port, two pieces alcohol pads
• 16946430400441: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, two pieces alcohol pads an
• 16946430400427: Cardiopulmonary resuscitation kit contains Infant CPR Mask without Oxygen Port, two pieces alcoh
• 16946430400397: The cardiopulmonary resuscitation aid kit comprises of one CPR Mask without Oxygen Port, two pie
• 06946430400383: The Cardiopulmonary Resuscitation Aid Kit comprises of one CPR Mask with Oxygen Port, two piece
• 16946430400373: Cardiopulmonary resuscitation kit contains Infant CPR Mask without Oxygen Port and one pair Nitr
• 16946430400366: Cardiopulmonary resuscitation kit contain CPR Mask without Oxygen Port and one pair nitril glove
• 16946430400359: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port and one pair Nitril glove.
• 16946430400342: Cardiopulmonary resuscitation kit contains Infant CPR Mask without Oxygen Port and one pair PVC
• 16946430400335: Cardiopulmonary resuscitation kit contains CPR Mask without Oxygen Port and one pair PVC glove.
• 16946430400328: Cardiopulmonary resuscitation kit contains Infant CPR Mask without Oxygen Port and two pieces al
• 16946430400311: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port and one pair PVC glove. CPR
• 16946430400304: Cardiopulmonary resuscitation kit contains CPR Mask without Oxygen Port and two pieces alcohol p
• 06946430400291: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port and two pieces alcohol pads
• 26946430400288: It is a single-use, non-sterile device intended to be used with a ventilation mask to provide mo
• 26946430400271: It is a single-use, non-sterile device intended to be used with a ventilation mask to provide mo
• 16946430400267: It is a single-use, non-sterile device intended to be used with a ventilation mask to provide mo
• 16946430400250: It is a single-use, non-sterile device intended to be used with a ventilation mask to provide mo
• 16946430400243: It is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmon
• 16946430400236: It is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmon
• 16946430400229: It is designed for mouth to mask ventilation to health emergency patients requiring oxygen suppo
• 16946430400212: It is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmon
• 16946430400205: It is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmon
• 16946430400199: It is designed for mouth to mask ventilation to health emergency patients requiring oxygen suppo
• 16946430400182: It is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmon
• 06946430400161: It is designed for mouth to mask ventilation to health emergency patients requiring oxygen suppo
• 06946430410887: The intended use for Infant Disposable Manual Resuscitator: Single patient use manual resuscita
• 16946430410877: The intended use for Infant Disposable Manual Resuscitator: Single patient use manual resuscitat
• 16946430410860: The intended use for Child Disposable Manual Resuscitator: Single patient use manual resuscitato
• 16946430410853: The inteneded use for Child Disposable Manual Resuscitator: Single patient use manual resuscitat
• 16946430410846: The intended use for Adult Disposable Manual Resuscitator: Single patient use manual resuscitato
• 16946430410839: Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital
• 06946430412942: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia mas
• 16946430413328: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia mas
• 16946430413342: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia mas
• 16946430413335: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia mas
• 16946430414059: Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
• 16946430415186: CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to ma