AccessGUDID - DEVICE: BLOOD TUBING LINES FOR HEMODIALYSIS (04987671201102)

GUDID

Device Identifier (DI) Information

Brand Name: BLOOD TUBING LINES FOR HEMODIALYSIS
Version or Model: AV06C-P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIKKISO CO.,LTD.

Primary DI Number: 04987671201102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690542378 *Terms of Use

Device Description: The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the NIKKISO DBB-06 Hemodialysis Delivery System.

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?
34999	Haemodialysis blood tubing set, single-use	A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOC	Accessories, Blood Circuit, Hemodialysis

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
No Device Sizes

Device Record Status

Public Device Record Key: 0d919b91-fdc3-4325-8d7f-e71b28239142
Public Version Date: November 09, 2020
Public Version Number: 1
DI Record Publish Date: October 30, 2020