AccessGUDID - DEVICE: ADULT ANGLED B/V FILTER + LUER PORT (05055788742579)

GUDID

Device Identifier (DI) Information

Brand Name: ADULT ANGLED B/V FILTER + LUER PORT
Version or Model: 038-41-345U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FLEXICARE MEDICAL LIMITED

Primary DI Number: 05055788742579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 504406273 *Terms of Use

Device Description: No description.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Microbial medical gas filter, non-sterile, single-use	A non-sterile 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.

FDA Product Code

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Product Code	Product Code Name
CAH	Filter, Bacterial, Breathing-Circuit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092218	000

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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d348834-4c4c-4f08-bf14-05296a10cfd6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 10, 2016