AccessGUDID - DEVICE: Firefly Transfer Catheter (00865349000315)

GUDID

Device Identifier (DI) Information

Brand Name: Firefly Transfer Catheter
Version or Model: 40398
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PURACATH MEDICAL, INC

Primary DI Number: 00865349000315
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 963236661 *Terms of Use

Device Description: Perotineal Dialysis Transfer Catheter

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?
47086	Peritoneal dialysis catheter, chronic	A tube used to infuse a solution (dialysate) into the peritoneal cavity, allowing metabolic wastes/fluid to diffuse from the blood to the dialysate using the peritoneum as the dialysing membrane. It is usually surgically or endoscopically implanted, percutaneously, for long-term use; it may be provided with Dacron cuffs to promote tissue ingrowth for the prevention of fluid leaks and bacterial penetration. It may be used in manual continuous ambulatory peritoneal dialysis (CAPD), automated continuous cyclic peritoneal dialysis, intraperitoneal chemotherapy, or to eliminate fluid overload in congestive heart failure. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 20d837bf-3dcc-4ded-8d8b-6b9829145960
Public Version Date: July 10, 2020
Public Version Number: 3
DI Record Publish Date: November 21, 2016