AccessGUDID - DEVICE: Hemoflow™ (00840861100064)

GUDID

Device Identifier (DI) Information

Brand Name: Hemoflow™
Version or Model: 0500154A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Fresenius Medical Care Holdings, Inc.

Primary DI Number: 00840861100064
Issuing Agency: GS1
Commercial Distribution End Date: August 07, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 958291411 *Terms of Use

Device Description: F80A Hemoflow Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL

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:	No
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?
47071	Hollow-fibre haemodialysis dialyser, reusable	A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-patient, reusable device after high-level disinfection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSF	HEMODIALYZER, RE-USE, HIGH FLUX

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 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 1.8 Square meter

Device Record Status

Public Device Record Key: 122cf55f-e3df-4ae5-bbbe-1febd4a26c56
Public Version Date: August 12, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2015