AccessGUDID - DEVICE: EZE-VAC® 3300ML DISPOSABLE SUCTION CANISTER (30704411000338)

GUDID

Device Identifier (DI) Information

Brand Name: EZE-VAC® 3300ML DISPOSABLE SUCTION CANISTER
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 432130411
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 30704411000338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: EZE-VAC® 3300ML DISPOSABLE SUCTION CANISTER

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?
38476	Suction system bottle	A cylindrical sealable container made of glass or plastic (typically chemical resistant) that is used as a component of a suction system, or other system that utilizes suction, for the collection of aspirated waste materials (e.g., blood, bodily fluids, laser plume evacuation gas) and/or body tissue intended for diagnostic/therapeutic purposes (e.g., histological analysis, autologous fat tissue transfer) from a site of operation. It may be used singularly or in a connected series to provide greater capacity, and may be calibrated to facilitate determination of the quantity of its contents. Suction system bottles are not used in conjunction with suction liners. This is a reusable device.	Obsolete	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: b1d57c77-adda-4f47-ae14-18a9acf2af8f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016