AccessGUDID - DEVICE: POLYFLUX (07332414041472)

GUDID

Device Identifier (DI) Information

Brand Name: POLYFLUX
Version or Model: 8LR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 104333
Company Name: Gambro Dialysatoren GmbH

Primary DI Number: 07332414041472
Issuing Agency: GS1
Commercial Distribution End Date: April 09, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 316150549 *Terms of Use

Device Description: The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient

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
KDI	Dialyzer, high permeability with or without sealed dialysate system
FJI	DIALYZER, CAPILLARY, HOLLOW FIBER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043342	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: less than 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 35a91a5b-3a97-453b-85bd-824216dc13ee
Public Version Date: July 27, 2023
Public Version Number: 6
DI Record Publish Date: October 12, 2015