SSUmini JG 3/8

GUDID 10866318000302

SSUmini JG 3/8 and packaging information 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.).

NEPHROS, INC.

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Primary Device ID	10866318000302
NIH Device Record Key	682c8bbe-b456-4e25-a6a4-095683b7679c
Commercial Distribution Status	In Commercial Distribution
Brand Name	SSUmini JG 3/8
Version Model Number	70-0251C
Company DUNS	120664557
Company Name	NEPHROS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866318000305 [Primary]
GS1	10866318000302 [Package] Contains: 00866318000305 Package: Carton [25 Units] In Commercial Distribution

FDA Product Code

FIP	Subsystem, Water Purification

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[10866318000302]

High-level Disinfectant

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[10866318000302]

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[10866318000302]

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[10866318000302]

High-level Disinfectant

[10866318000302]

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[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

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[10866318000302]

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[10866318000302]

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[10866318000302]

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[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

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[10866318000302]

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[10866318000302]

High-level Disinfectant

[10866318000302]

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[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

High-level Disinfectant

[10866318000302]

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High-level Disinfectant

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-11-15
Device Publish Date	2017-12-31

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