AccessGUDID - DEVICE: Renaflo II HF 2000 Hemofilter (00677964000096)

GUDID

Device Identifier (DI) Information

Brand Name: Renaflo II HF 2000 Hemofilter
Version or Model: 93024-225
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 93024225
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964000096
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 HF 2000 Hemofilter

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?
35433	Particulate water purification filter	A device designed to remove sediment and other suspended particles from flowing water by creating a mechanical barrier to elements larger than a specified size (e.g., 5 to 10 microns/micrometres); it is often made of polypropylene filaments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, water purification

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: No
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: f28c5989-2874-4481-a7a7-6877e6a773e3
Public Version Date: June 07, 2024
Public Version Number: 2
DI Record Publish Date: July 18, 2023