AccessGUDID - DEVICE: Aquaboss® (04046964859748)

GUDID

Device Identifier (DI) Information

Brand Name: Aquaboss®
Version or Model: LA1107128
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LA1107128
Company Name: LAUER Membran Wassertechnik GmbH

Primary DI Number: 04046964859748
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328246251 *Terms of Use

Device Description: EcoRO Dia II 1250

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
FIP	SUBSYSTEM, WATER PURIFICATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K124059	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

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Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a3b7615d-ed71-47b0-82e9-d083c0f7e81e
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 23, 2016