AccessGUDID - DEVICE: Sunset Portable Suction Machine with AC/DC Power (00848530102579)

GUDID

Device Identifier (DI) Information

Brand Name: Sunset Portable Suction Machine with AC/DC Power
Version or Model: SU100DPA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530102579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Sunset Portable Suction Machine with AC/DC Power, 800cc Canister, Detachable Power Cord, Carry Case & Car Adapter

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:	Yes
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?
60331	Pneumatic line tester, battery-powered	A portable, battery-powered, general-purpose device intended to measure pneumatic line flow rates and pressures (positive and negative) in order to calibrate or test a medical (e.g., anaesthesia machines, suction devices) or industrial device and is not dedicated to a specific discipline. It typically consists of a hand-held electronic box with appropriate pneumatic line connections, a digital display and might also contain built-in sensors (e.g., thermometer, hygrometer) in order to measure additional properties (e.g., atmospheric pressure, humidity and temperature). It is intended to be used by a professional in a professional setting (e.g., clinical engineering).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102626	000

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: 52d02887-389e-4a83-a11c-a56f0c79d691
Public Version Date: March 13, 2024
Public Version Number: 1
DI Record Publish Date: March 05, 2024