AccessGUDID - DEVICE: VAC-GARD® EXTERNAL SHUTOFF VALVE (10704411000495)

GUDID

Device Identifier (DI) Information

Brand Name: VAC-GARD® EXTERNAL SHUTOFF VALVE
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 433090421
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411000495
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: VAC-GARD® EXTERNAL SHUTOFF VALVE

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?
36778	General-purpose suction system, vacuum	An assembly of devices designed to evacuate fluid, tissue, gas, or foreign materials from a body cavity or lumen by means of suction. It is connected via dedicated vacuum tubing to the vacuum terminal unit (wall outlet) of a vacuum pipeline system and powered via a hospital's central vacuum system. It generally includes a regulator, tubing, an overflow trap, plastic/glass collection container(s), a suction tip, and possibly moisture/microbial filters. The regulator controls the vacuum in the suction tubing for the removal of materials into the collection container. This system can be used in a wide variety of hospital settings, but is limited to connection to a central vacuum system.	Obsolete	false

FDA Product Code

[?]

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f2595fa-4232-4b75-b13c-8a0dff84a056
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016