AccessGUDID - DEVICE: n/a (04250105608595)

GUDID

Device Identifier (DI) Information

Brand Name: n/a
Version or Model: 30-01-003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 04250105608595
Issuing Agency: GS1
Commercial Distribution End Date: April 14, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use

Device Description: Manujet III including Jet-Ventilations Catheters

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 [?]
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
No Device Sizes

Device Record Status

Public Device Record Key: e1d2d0b4-12ab-4008-bbab-f05018233b58
Public Version Date: April 15, 2021
Public Version Number: 3
DI Record Publish Date: April 17, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +49745495960
Email: info@vbm-medical.de

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