AccessGUDID - DEVICE: AirLife™ (10190752114432)

GUDID

Device Identifier (DI) Information

Brand Name: AirLife™
Version or Model: 2K8037
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2K8037
Company Name: AIRLIFE

Primary DI Number: 10190752114432
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119058668 *Terms of Use

Device Description: AirLife™ Pediatric Manual Resuscitator; 40"(1.0m) Oxygen Resevoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock

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:	Yes
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?
35425	Non-rebreathing valve, reusable	A non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable 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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1000.00 Milliliter
Weight: .40 Kilogram

Device Record Status

Public Device Record Key: 15132b8e-a737-492c-a006-64f3aaef1680
Public Version Date: April 17, 2025
Public Version Number: 5
DI Record Publish Date: December 20, 2019