AccessGUDID - DEVICE: Suction Kit (00848530088781)

GUDID

Device Identifier (DI) Information

Brand Name: Suction Kit
Version or Model: APRO030SKIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: APRO030SKIT
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530088781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Suction Kit (1 Kit), This Kit Contains: 1 RES025 Suction Tubing 6ft, 1 BF516TS Bacteria Filter 5/16in Barbed with Threaded NPT, 1 RES024XL Suction Tube Connector 16in, 1 RES023S Suction Canister 800cc, 1 RES028 Rubber Suction Elbow Connector.

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?
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
BZD	Ventilator, Non-Continuous (Respirator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d41c131-63fa-48a9-a93a-c263991681b0
Public Version Date: July 11, 2018
Public Version Number: 2
DI Record Publish Date: May 29, 2018