AccessGUDID - DEVICE: AquaBplus (04251285200289)

GUDID

Device Identifier (DI) Information

Brand Name: AquaBplus
Version or Model: AquaBplus B2 2500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VIVONIC GmbH

Primary DI Number: 04251285200289
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341685795 *Terms of Use

Device Description: Additional membrane filtration unit for AquaBplus Water Treatment Systems. AquaBplus B2 Unit for: AquaBplus & AquaBplus B2 2500 (Primary DI No.: 04251285200111) AquaBplus & AquaBplus B2 & AquaBplus HF 2500 (Primary DI No.: 04251285200227)

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):	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?
14437	Reverse-osmosis water purification system	An assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133829	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
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: 10f3d3e7-1b9c-4c7e-973f-22102323d5b2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016