AccessGUDID - DEVICE: Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter (00852250006079)

GUDID

Device Identifier (DI) Information

Brand Name: Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter
Version or Model: PD4103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PD4103
Company Name: LIFEMED OF CALIFORNIA

Primary DI Number: 00852250006079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152680815 *Terms of Use

Device Description: Pediatric Acute Tenckhoff Peritoneal Catheter with Radiopaque Stripe and One Attached Cuff

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?
47084	Peritoneal dialysis catheter, acute	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 percutaneously inserted for one-session dialysis in an acute setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FKO	Catheter, Peritoneal Dialysis, Single Use

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 28 Centimeter
Outer Diameter: 4.69 Millimeter
Lumen/Inner Diameter: 2.66 Millimeter

Device Record Status

Public Device Record Key: f18968bd-5f50-4341-b29d-bc9d7e55c7a1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 06, 2015