AccessGUDID - DEVICE: AirLife (10190752141797)

GUDID

Device Identifier (DI) Information

Brand Name: AirLife
Version or Model: CHB0020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIRLIFE

Primary DI Number: 10190752141797
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119058668 *Terms of Use

Device Description: WATER STERILE IN HANGING BOTTLE 2000mL

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?
44706	Inhalation therapy sterile water	A quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: exactly 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7e8c736-5653-42a1-b281-d29d7f017f46
Public Version Date: April 17, 2025
Public Version Number: 3
DI Record Publish Date: March 24, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50190752141795	8	10190752141797		In Commercial Distribution	Case

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: Yes
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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