AccessGUDID - DEVICE: Spiral Tubing, Trans Red (00858293006700)

GUDID

Device Identifier (DI) Information

Brand Name: Spiral Tubing, Trans Red
Version or Model: 1W-013-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REPROCESSING PRODUCTS CORPORATION

Primary DI Number: 00858293006700
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796083392 *Terms of Use

Device Description: Spiral Coil Tubing 1/16 x 8, Trans Red

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):	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?
63863	Haemodialysis dialysate tubing, reusable	A length of tube made of metal and/or synthetic polymer materials intended to deliver haemodialysis dialysate and/or haemodialysis dialysate components (water, haemodialysis concentrate) to and/or from a haemodialysis machine/system. This is a reusable device.	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: c8446bae-705d-44ff-8a4d-515be9b5b2d1
Public Version Date: May 17, 2021
Public Version Number: 2
DI Record Publish Date: August 30, 2019