AccessGUDID - DEVICE: Exsudex disposable canister (08718104890091)

GUDID

Device Identifier (DI) Information

Brand Name: Exsudex disposable canister
Version or Model: NewERA II disposable canister with tube and connector
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 16690-NEWERA
Company Name: Meditop B.V.

Primary DI Number: 08718104890091
Issuing Agency: GS1
Commercial Distribution End Date: July 09, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 387209518 *Terms of Use

Device Description: The Exsudex® Disposable Canister, commercially labelled as NewERA Disposable Canister, has the following features and is only to be used together with the NewERA II wound drainage system: - Canister capacity 300 cc; - Bacterial filter; - Fixed non-sterile suction tube with clamb and luer-lock connector - Dissolving sachet solidifying agent

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:	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?
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
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d74f8304-fffc-4f64-aa7c-9f407bb242a6
Public Version Date: November 28, 2022
Public Version Number: 8
DI Record Publish Date: February 07, 2018