AccessGUDID - DEVICE: GENTEC® (06970966663134)

GUDID

Device Identifier (DI) Information

Brand Name: GENTEC®
Version or Model: 880VS-760-CH/A-T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENTEC(SHANGHAI)CORPORATION

Primary DI Number: 06970966663134
Issuing Agency: GS1
Commercial Distribution End Date: March 11, 2042
Device Count: 1
Labeler D-U-N-S® Number*: 545287658 *Terms of Use

Device Description: 880VS series medical suction kit (aka suction kit) is a continuous suction kit powered from pressure gas. This is a long term, non-invasive, active medical device. It can be used to medical suction for tracheal suction, pharyngeal aspiration, gastro-intestinal drainage, and surgical suction.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
63650	General-purpose surgical suction system, pneumatic	An assembly of pneumatically-powered devices, which includes a surgically invasive component, designed to aspirate debris/tissues/fluids from body cavities/wounds during a surgical procedure; it may in addition have non-surgical applications. It is connected to the wall outlet of a compressed gas (e.g., air, oxygen) supply whereby positive gas pressure is converted into negative pressure/suction (the Venturi principle). The system includes a pneumatic suction regulator which controls the degree of negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDP	Regulator, 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: eb94e5d4-f85d-4bc6-9a61-f360bdd2dd41
Public Version Date: March 21, 2022
Public Version Number: 1
DI Record Publish Date: March 11, 2022