AccessGUDID - DEVICE: H2H Substitution Filter (00896241002077)

GUDID

Device Identifier (DI) Information

Brand Name: H2H Substitution Filter
Version or Model: 70-6828
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NEPHROS, INC.

Primary DI Number: 00896241002077
Issuing Agency: GS1
Commercial Distribution End Date: September 16, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 120664557 *Terms of Use

Device Description: H2H Substitution Filter and packaging information

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?
47334	Haemodialysis system dialysate pyrogen-filtration set	A collection of sterile devices designed to be used with a haemodialysis system for on-line filtration of the dialysate to remove bacteria and endotoxins during haemodialysis. This purified (filtered) dialysate is used for the replacement fluid (substitution solution). It includes tubing with an integrated filter(s), and typically connectors (e.g., Luer-lock) and a sampling port. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112314	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 225b8689-3a8b-449d-9f69-ad10415b37d7
Public Version Date: September 17, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016