AccessGUDID - DEVICE: AirLife (10885403287138)

GUDID

Device Identifier (DI) Information

Brand Name: AirLife
Version or Model: M1043237
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M1043237
Company Name: Carefusion Finland 320 Oy

Primary DI Number: 10885403287138
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 367919120 *Terms of Use

Device Description: FILTER HEPA W PLEATED MEDIA GSP 50/PK

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?
60837	Microbial medical gas filter, single-use	A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAH	Filter, bacterial, breathing-circuit

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: No
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: 43563f44-e6fb-4e7b-89e4-33ab84634a1d
Public Version Date: April 19, 2024
Public Version Number: 4
DI Record Publish Date: September 14, 2016