AccessGUDID - DEVICE: Flex-Neck® (00884450330135)

GUDID

Device Identifier (DI) Information

Brand Name: Flex-Neck®
Version or Model: 00884450330135
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CF-5247/C
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450330135
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *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?
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
FJS	Catheter, peritoneal, long-term indwelling

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
Device Size Text, specify: I.D. (mm)-3.5 mm
Device Size Text, specify: Overall Length Straight (cm)-52.0 cm
Device Size Text, specify: Catheter Tip configuration-Coiled
Device Size Text, specify: Number of Cuffs-1 Cuff

Device Record Status

Public Device Record Key: 1bc4ff0a-5353-4ad4-accb-0528f2e4d693
Public Version Date: October 11, 2021
Public Version Number: 6
DI Record Publish Date: October 16, 2017