FDA.report

Pocket BVM TM O2 tubing

Primary DI
07290016824032
Brand
Pocket BVM TM O2 tubing
Company
MICRO B.V.M. SYSTEMS LTD
Model
PBVM G (003XP)
Device description
"Pocket BVM is a manual emergency ventilator whose purpose is to manually apply positive pressure to a patient’s airways to support ventilation and ox
Published
2017-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications

CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290016824032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290016824032072900168240327290016824032

GMDN Terms

TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+97226517191INFO@MICROBVM.com

Regulatory Flags

DUNS number
514918791
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07290016824001Pocket BVM TM PBVM C (002)2017-03-29
07290016824063Pocket BVM ® cyclone Pocket BVM ® cyclone 2017-03-29
07290016824094Pocket BVM TM Tactical PBVM TAC 2017-03-29
07290016824124Pocket BVM TM Airway PBVM AW2017-03-29
07290016824155Pocket BVM TM NuMask PBVM NM 2017-03-29
07290016824186Pocket BVM TM EXTMBVM EXT2017-03-29

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