AccessGUDID - DEVICE: Revaclear (07332414114923)

GUDID

Device Identifier (DI) Information

Brand Name: Revaclear
Version or Model: 400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 114746
Company Name: Gambro Dialysatoren GmbH

Primary DI Number: 07332414114923
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316150549 *Terms of Use

Device Description: Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by Hemodialysis

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?
47072	Hollow-fibre haemodialysis dialyser, single-use	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-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 [?]
K130039	000

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: less than 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 1.8 Square meter

Device Record Status

Public Device Record Key: 5bc0041b-ffd5-406e-8be0-08c2b9031e16
Public Version Date: August 10, 2023
Public Version Number: 7
DI Record Publish Date: October 12, 2015