AccessGUDID - DEVICE: Pocket BVM TM (07290016824001)

GUDID

Device Identifier (DI) Information

Brand Name: Pocket BVM TM
Version or Model: PBVM C (002)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MICRO B.V.M. SYSTEMS LTD

Primary DI Number: 07290016824001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514918791 *Terms of Use

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 oxygenation. The modified Pocket BVM incorporates bags and valve assemblies and is intended to provide emergency respiratory support to a patient through a tube inserted into the patient's airway or a face mask. The Pocket BVM device continues to maintain the functionality of existing devices and also has the advantage of small external dimensions (when packed) and light weight. It can be unpacked and made operational in seconds. "

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36086	Pulmonary resuscitator, manual, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTM	Ventilator, Emergency, Manual (Resuscitator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8d3d8c88-ab09-4fda-a46b-4a25e0d0d51d
Public Version Date: February 08, 2019
Public Version Number: 3
DI Record Publish Date: March 29, 2017