Connecting Tube for Manujet III

Basic Information

• Brand Name: Connecting Tube for Manujet III
• Primary DI: 04250105604283
• Version / Model: 54-05-111
• Company Name: VBM Medizintechnik GmbH
• Labeler DUNS: 324869601
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-13
• Public Version: 5
• Public Version Date: 2021-05-20
• Public Version Status: Update
• Public Device Record Key: 35d15345-e85f-45ec-b637-478c17842ae5

Device Description

n/a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	868.5975	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14250105604280	GS1		10	Not in Commercial Distribution	2021-04-14
Primary	04250105604283	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	100	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry, Keep away from sunlight and heat