AccessGUDID - DEVICE: AmeriWater MROS (00817927020000)

GUDID

Device Identifier (DI) Information

Brand Name: AmeriWater MROS
Version or Model: MROS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERIWATER, LLC

Primary DI Number: 00817927020000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 836758342 *Terms of Use

Device Description: MROS, Single Patient Portable RO, 730 GPD, 115V

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 [?]
K111740	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Peracetic Acid
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 41 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 135 Pound
Depth: 24 Inch
Width: 17 Inch
Height: 47 Inch

Device Record Status

Public Device Record Key: 8c0a38d8-e28a-4818-ad35-655d07cf0fb7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 05, 2017

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)

[?]

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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