AccessGUDID - DEVICE: Intake Bacteria Filters (00848530010492)

GUDID

Device Identifier (DI) Information

Brand Name: Intake Bacteria Filters
Version or Model: BF2222
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BF2222
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530010492
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Intake Bacteria Filters (5/pack)

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:	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31245	Anaesthesia conduction filter	A sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRL	Unit, Filter, Membrane

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b5383d6b-2cce-40f6-ab70-f3396266062d
Public Version Date: August 31, 2018
Public Version Number: 1
DI Record Publish Date: July 31, 2018