AccessGUDID - DEVICE: SYSTEM 83 PLUS (SYSTEM83PLUS2)

GUDID

Device Identifier (DI) Information

Brand Name: SYSTEM 83 PLUS
Version or Model: SYSTEM 83 PLUS 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Wassenburg Medical, Inc.

Primary DI Number: SYSTEM83PLUS2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118762097 *Terms of Use

Device Description: A device to disinfect endoscopes

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:	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?
35012	Endoscope washer/disinfector	A mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes, and their accessories, with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FEB	Accessories, Cleaning, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: between 0 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Do not fork lift
Special Storage Condition, Specify: Fragile

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 94e3e4b5-88e4-435e-b127-435fe35bd279
Public Version Date: July 03, 2023
Public Version Number: 6
DI Record Publish Date: September 25, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B21583PLUS2	1	SYSTEM83PLUS2		In Commercial Distribution	Corrugated Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 215-364-1477
Email: info@customultrasonics.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES