AccessGUDID - DEVICE: N/A (04250105604283)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 54-05-111
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 04250105604283
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use

Device Description: Connecting Tube for Manujet III

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:	Yes
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112783	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
Special Storage Condition, Specify: Keep dry, Keep away from sunlight and heat

Clinically Relevant Size

[?]

Size Type Text
Length: 100 Centimeter

Device Record Status

Public Device Record Key: 35d15345-e85f-45ec-b637-478c17842ae5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 13, 2016