AccessGUDID - DEVICE: TQE Plus Endotoxin 10" Filter Flat 222 Head (00868277000419)

GUDID

Device Identifier (DI) Information

Brand Name: TQE Plus Endotoxin 10" Filter Flat 222 Head
Version or Model: TQE0.005-10P3E
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NEPHROS, INC.

Primary DI Number: 00868277000419
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 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?
33627	Peritoneal dialysis system dialysate filter	A microporous device used to capture contamination particles of the dialysate before its instillation into the peritoneal cavity. 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 [?]
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: fbeb2ecb-ae47-4bcd-b198-062e1cd527b6
Public Version Date: February 14, 2024
Public Version Number: 6
DI Record Publish Date: December 21, 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
10868277000416	1	00868277000419	2024-02-13	Not in Commercial Distribution	1 part per box
20868277000413	30	10868277000416	2024-02-13	Not in Commercial Distribution	30 boxes per Carton