AccessGUDID - DEVICE: TQE Plus Endotoxin 10" Filter Flat 222 Head (00868277000440)

GUDID

Device Identifier (DI) Information

Brand Name: TQE Plus Endotoxin 10" Filter Flat 222 Head
Version or Model: TQE0.005-10HP3E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEPHROS, INC.

Primary DI Number: 00868277000440
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 120664557 *Terms of Use

Device Description: The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.

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?
47739	Haemodialysis system dialysate pyrogen filter	A sterile device designed to be used with a haemodialysis system for filtration of dialysate during haemodialysis to remove bacteria and endotoxins and produce purified dialysate for the procedure. It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis. It typically consists of a plastic housing, containing a hollow fibre membrane, with appropriate connectors at either end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161304	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Liquid Chemical

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: 69ac3265-a05b-4211-8580-b59391d60ac7
Public Version Date: February 14, 2024
Public Version Number: 2
DI Record Publish Date: September 16, 2021