DEVICE: Connecting Tube for Manujet III (04250105604283)
Device Identifier (DI) Information
Connecting Tube for Manujet III
54-05-111
In Commercial Distribution
VBM Medizintechnik GmbH
54-05-111
In Commercial Distribution
VBM Medizintechnik GmbH
n/a
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
---|---|
BZO | Set, Tubing And Support, Ventilator (W Harness) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
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
35d15345-e85f-45ec-b637-478c17842ae5
May 20, 2021
5
May 13, 2016
May 20, 2021
5
May 13, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14250105604280 | 10 | 04250105604283 | 2021-04-14 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49745495960
info@vbm-medial.de
info@vbm-medial.de