AccessGUDID - DEVICE: SüpeVac – Portable Single Use Hand-Held Suction Device (00860004198857)

GUDID

Device Identifier (DI) Information

Brand Name: SüpeVac – Portable Single Use Hand-Held Suction Device
Version or Model: CM200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CM200
Company Name: GMMI SDN. BHD.

Primary DI Number: 00860004198857
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 865757421 *Terms of Use

Device Description: No description.

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":	Yes
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?
47367	Emergency airway clearance suction system, pneumatic	A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart), by means of suction generated from a compressed gas supply (the Venturi principle). It includes a pneumatic suction regulator which controls the degree of negative pressure for aspiration, a portable supply of compressed gas (e.g., cylinder of air or oxygen), collection containers, tubing, microbial/hydrophobic filters, and patient contact devices (e.g., handpiece/tip, mask).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	Bottle, Collection, Vacuum

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: 701139ce-f311-46dd-a917-8e41a7a55430
Public Version Date: June 02, 2025
Public Version Number: 1
DI Record Publish Date: May 23, 2025