AccessGUDID - DEVICE: 492A, 590 and 592 Kit (00848530050634)

GUDID

Device Identifier (DI) Information

Brand Name: 492A, 590 and 592 Kit
Version or Model: OF6001SP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF6001SP
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530050634
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: This kit contains: 2 OF6001 Foam Cabinet Filters, 1 BF5000 Extended Life Bacteria Filter, 1 BF316 Final Bacteria Filter.

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:	Yes
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
No Product Codes

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: 0ad3f284-6b9a-4b1e-9fec-cd94cc2d4d6f
Public Version Date: August 31, 2018
Public Version Number: 1
DI Record Publish Date: July 31, 2018