AccessGUDID - DEVICE: AirLife™ (10190752142008)

GUDID

Device Identifier (DI) Information

Brand Name: AirLife™
Version or Model: 4682A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4682A
Company Name: AIRLIFE

Primary DI Number: 10190752142008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119058668 *Terms of Use

Device Description: Tracheostomy Cleaning Tray

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:	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?
14090	Tracheostomy care kit, single-use	A collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OFP	Anesthesia breathing circuit kit (adult & pediatric)

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: 692fb537-bca0-47e7-aacb-be8c4907e45a
Public Version Date: April 17, 2025
Public Version Number: 3
DI Record Publish Date: September 05, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50190752142006	20	10190752142008		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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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