AccessGUDID - DEVICE: SSUmini JG 3/8 (00866318000305)

GUDID

Device Identifier (DI) Information

Brand Name: SSUmini JG 3/8
Version or Model: 70-0251C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NEPHROS, INC.

Primary DI Number: 00866318000305
Issuing Agency: GS1
Commercial Distribution End Date: February 13, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 120664557 *Terms of Use

Device Description: The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).

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:	Yes
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?
58088	Microbial water purification filter, non-sterilizable	A sterile device designed to remove bacteria and other suspended particles from flowing water by creating a mechanical barrier to elements larger than 0.2 micrometres. It typically consists of a plastic housing with a connector to the water source [e.g., a tap (faucet)] and a 0.2 micrometre filtering membrane [e.g., made of nylon, polyvinylidene fluoride (PVDF), or polyethersulfone (PES)]; a prefiltration of the water to remove larger particles is typically recommended. It is typically used for hygienic and surgical hand washing, wound irrigation, and/or rinsing of medical devices. This is a disposable, non-sterilizable device which may serve multiple patients before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110285	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 682c8bbe-b456-4e25-a6a4-095683b7679c
Public Version Date: November 11, 2024
Public Version Number: 7
DI Record Publish Date: December 31, 2017