AccessGUDID - DEVICE: ZOOM™ Duoport Canister (04719876940186)

GUDID

Device Identifier (DI) Information

Brand Name: ZOOM™ Duoport Canister
Version or Model: TDC001B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Taiwan Biomaterial Company Limited

Primary DI Number: 04719876940186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656073408 *Terms of Use

Device Description: An accessories of Zoom Asipration Pump. Commercial prodcut name (Brand name): ZOOM™ Duoport Canister Model number: TDC001B

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):	Yes
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?
65275	Thrombectomy electric suction pump, reusable	An electrically-powered pump designed specifically to aspirate clotted blood (e.g., thrombi, emboli), or other formed elements, from vessels of the arterial and venous systems to treat vascular obstruction and restore blood flow. It generates a negative pressure for aspiration and may be provided with collection containers, syringe and tubing; it is typically intended to be connected to a patient contact catheter (not included). This is a reusable device.	Active	false
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190105	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Keep dry. Keep away from sunlight. Store at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 16db3e95-ecb0-4865-b0c0-efa6580abe0d
Public Version Date: March 04, 2025
Public Version Number: 1
DI Record Publish Date: February 24, 2025