AccessGUDID - DEVICE: HEMODIALYSIS DELIVERY SYSTEM (04987671060006)

GUDID

Device Identifier (DI) Information

Brand Name: HEMODIALYSIS DELIVERY SYSTEM
Version or Model: DBB-06
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIKKISO CO.,LTD.

Primary DI Number: 04987671060006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690542378 *Terms of Use

Device Description: The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

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):	Yes
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

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34994	Haemodialysis system dialysate delivery unit	An electrically-powered integral unit of a haemodialysis system that prepare and delivers the haemodialysis dialysate solution to the haemodialysis dialyser where it is used in the treatment of the patient (one patient only). It monitors and controls such indicators as temperature, conductivity, flow rate, and pressure.	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 [?]
K152938	000

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
Special Storage Condition, Specify: Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
Storage Environment Temperature: between -20 and 60 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f20b6d6b-36f8-42ae-b9bb-fb59a9a0bd31
Public Version Date: June 09, 2023
Public Version Number: 4
DI Record Publish Date: August 12, 2016