AccessGUDID - DEVICE: N/A (10190752143838)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: M1045564
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M1045564
Company Name: AIRLIFE

Primary DI Number: 10190752143838
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119058668 *Terms of Use

Device Description: Intratracheal Pressure Sensor

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":	No
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61458	Tracheal pressure catheter	A sterile device intended to be used for monitoring the endotracheal pressure of a mechanically ventilated patient. It consists of a Y-piece component that connects an endotracheal tube to a breathing circuit, with a port for an included sensing catheter to be inserted and advanced through the endotracheal tube into the trachea. It is proximally connected to a parent device (e.g., ventilator), which will measure and display the detected endotracheal pressure. It is typically made of plastic material [e.g., polyvinyl chloride (PVC)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXO	Transducer, Gas Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 68bc68cb-46ed-4068-bb2e-a8bf4c8956bf
Public Version Date: April 17, 2025
Public Version Number: 4
DI Record Publish Date: December 15, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20190752143835	10	10190752143838		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)

[?]

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1-833-327-3284
Email: customersupport@vyaire.com

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