N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04250105615456
• Version / Model: 30-01-023
• Company Name: VBM Medizintechnik GmbH
• Labeler DUNS: 324869601
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-13
• Public Version: 4
• Public Version Date: 2021-04-15
• Public Version Status: Update
• Public Device Record Key: 538ab416-e637-41f9-80d1-96c33f5896f7
• Distribution End Date: 2021-04-14

Device Description

Manujet III

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	868.5925	2

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
Primary	04250105615456	GS1
Package	14250105615453	GS1		1	Not in Commercial Distribution	2021-04-14

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112783	000

Storage Conditions

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