AccessGUDID - DEVICE: Manual Jet Ventilator (M996BE183SUR0)

GUDID

Device Identifier (DI) Information

Brand Name: Manual Jet Ventilator
Version or Model: BE 183-SUR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BE 183-SUR
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996BE183SUR0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: The BE 183-SUR Manual Jet Ventilator is designed to provide trans-tracheal ventilation in specific emergency situations of upper airway obstructions. This system is used in conjunction with a trans-tracheal catheter, or cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by the manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
61724	Manual jet ventilation device	A portable, manually-operated, noninvasive device intended to be used in conjunction with a separate compressed oxygen (O2) source and airway access device (e.g., cricothyrotomy kit) for transtracheal ventilation of a patient in an emergency situation where there is complete or partial obstruction of the airways. It includes a small unit with an on/off button, which a healthcare professional is intended to manually turn on to release O2 for patient inspiration and turn off to allow expiration; it may also include medical grade tubing and a medical gas regulator for connection to higher pressure (e.g., >50psi) O2 sources; it is not intended to provide automated ventilation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTL	Ventilator, Emergency, Powered (Resuscitator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991785	000

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: 51ec7f64-4f01-45bf-b052-58ae3aeec21d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 19, 2015