AccessGUDID - DEVICE: Suction Component Kit (00848530085568)

GUDID

Device Identifier (DI) Information

Brand Name: Suction Component Kit
Version or Model: RES024XLKIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RES024XLKIT
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530085568
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: 1 RES024XL Suction Tubing Connector 6in, 1 RES028 Elbow Connector, 1 BF516TS 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?
13846	Secretion suction kit	A collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.	Obsolete	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: 1ee3a61e-aaa1-4103-8c01-f03e031a9f8b
Public Version Date: August 31, 2018
Public Version Number: 1
DI Record Publish Date: July 31, 2018