AccessGUDID - DEVICE: Filter CareStar 40A (04048675041245)

GUDID

Device Identifier (DI) Information

Brand Name: Filter CareStar 40A
Version or Model: MP01765
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Drägerwerk AG & Co. KGaA

Primary DI Number: 04048675041245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 315578914 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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 [?]
K072002	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

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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: ba8902a5-fb87-4aa7-a12c-ccc8fd608002
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015