AccessGUDID - DEVICE: Plastic Intake Nebulizer Filters (00848530086480)

GUDID

Device Identifier (DI) Information

Brand Name: Plastic Intake Nebulizer Filters
Version or Model: BF026S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BF026S
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530086480
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Plastic Intake Nebulizer Filters for Respironics Innospire Elegance, Essence & Deluxe (10/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: 3b9a9b81-cf12-4ed4-9f98-f1082266adaa
Public Version Date: August 17, 2018
Public Version Number: 2
DI Record Publish Date: June 29, 2018