AccessGUDID - DEVICE: Renaflo II Hemofilter (00677964000089)

GUDID

Device Identifier (DI) Information

Brand Name: Renaflo II Hemofilter
Version or Model: HF 1200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 93024328
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964000089
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: Renaflo II Hemofilter HF 1200

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):	No
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?
44601	Haemofilter	A filter used in the process of haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a system to allow for the removal of toxins and/or the replacement of electrolytes. The device functions with dialysate solution for the transfer of substances by diffusion and convection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 20 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a3e2831b-5232-44b8-9cbb-59acb271ddc4
Public Version Date: June 07, 2024
Public Version Number: 6
DI Record Publish Date: February 08, 2019