AccessGUDID - DEVICE: Dialyzer Dialysate QD to 45° Angle Hose Barb Red (00858293006779)

GUDID

Device Identifier (DI) Information

Brand Name: Dialyzer Dialysate QD to 45° Angle Hose Barb Red
Version or Model: D300-0105
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REPROCESSING PRODUCTS CORPORATION

Primary DI Number: 00858293006779
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796083392 *Terms of Use

Device Description: No description.

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):	No
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?
34993	Haemodialysis dialysate central supply system	An assembly of devices intended to supply large-scale haemodialysis dialysate (concentrate and/or ready-to-use solution) to medical facility haemodialysis systems for preparation/mixing and/or direct use. The system is typically built into the facility and consists of a pump(s) which applies positive pressure at a pre-set rate to supply the solution, storage tank(s), connection pipe(s), pressure and/or quantity sensor(s), and a control panel.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MON	System, Hemodialysis, Remote Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6787d571-95e5-4398-bbaa-8ea9104a889e
Public Version Date: September 09, 2019
Public Version Number: 1
DI Record Publish Date: August 30, 2019