AccessGUDID - DEVICE: VACUTRON (00260720006083)

GUDID

Device Identifier (DI) Information

Brand Name: VACUTRON
Version or Model: MINI-VAC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22-14-0200-B
Company Name: ALLIED HEALTHCARE PRODUCTS, INC.

Primary DI Number: 00260720006083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 099674145 *Terms of Use

Device Description: HIGH VACUUM SUCTION REGULATORS

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Neurosurgical suction regulator	A device designed to be attached to a suction system to control the degree of negative pressure (suction) applied in the evacuation of fluids, solids, or gases from the body during a neurosurgical procedure where the precise level of suction can be critical, e.g., during cranial surgery. The device is typically mounted onto the suction system and is connected with tubing between the suction system's pump and the collection container; it has two or more pre-set levels that are selected by the operator (the surgeon) using a foot-switch.

GMDN Preferred Term Name

GMDN Definition

Neurosurgical suction regulator

A device designed to be attached to a suction system to control the degree of negative pressure (suction) applied in the evacuation of fluids, solids, or gases from the body during a neurosurgical procedure where the precise level of suction can be critical, e.g., during cranial surgery. The device is typically mounted onto the suction system and is connected with tubing between the suction system's pump and the collection container; it has two or more pre-set levels that are selected by the operator (the surgeon) using a foot-switch.

FDA Product Code

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Product Code	Product Code Name
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a71a18ca-1148-4d3d-8761-778d70a8cdff
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 15, 2016