DEVICE: Aquaboss® (04046964859748)
Device Identifier (DI) Information
Aquaboss®
LA1107128
In Commercial Distribution
LA1107128
LAUER Membran Wassertechnik GmbH
LA1107128
In Commercial Distribution
LA1107128
LAUER Membran Wassertechnik GmbH
EcoRO Dia II 1250
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FIP | SUBSYSTEM, WATER PURIFICATION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K124059 | 000 |
Sterilization
Storage and Handling
[?]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
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a3b7615d-ed71-47b0-82e9-d083c0f7e81e
July 06, 2018
4
September 23, 2016
July 06, 2018
4
September 23, 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 |
---|---|---|---|---|---|
No Package DIs found |
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)848-2066
rtd.us@bbraun.com
rtd.us@bbraun.com