Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter PD4103

GUDID 00852250006079

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

LIFEMED OF CALIFORNIA

Peritoneal dialysis catheter, acute
Primary Device ID00852250006079
NIH Device Record Keyf18968bd-5f50-4341-b29d-bc9d7e55c7a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameLifemed Pediatric Acute Tenckhoff Peritoneal Catheter
Version Model NumberPD4103
Catalog NumberPD4103
Company DUNS152680815
Company NameLIFEMED OF CALIFORNIA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-543-3633
Emailinfo@lifemedofcalifornia.com

Device Dimensions

Lumen/Inner Diameter2.66 Millimeter
Lumen/Inner Diameter2.66 Millimeter
Lumen/Inner Diameter2.66 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852250006079 [Primary]
GS110852250006076 [Package]
Package: box [2 Units]
In Commercial Distribution

FDA Product Code

FKOCatheter, Peritoneal Dialysis, Single Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-06

Devices Manufactured by LIFEMED OF CALIFORNIA

10852250006038 - Lifemed Tubing Recirculating Set2019-06-07 Tubing Recirculating Set
20852250006042 - Lifemed Male to Male Luer Adapter2019-06-07 Male to Male Luer Adapter
10852250006052 - Lifemed Low Volume Tubing Set2019-06-07 Low Volume Tubing Set
10852250006069 - Lifemed 60 inch Monitor Line2019-06-07 60 inch (152 cm) Monitor Line
00852250006093 - Lifemed Line Clamp2019-03-28 Nonsterile Line Clamp, single external use
00852250006109 - Lifemed Coated Line Clamp2019-03-28 Nonsterile Coated Line Clamp, single external use
10852250006007 - Lifemed Chronic Tenckhoff Peritoneal Catheter2018-03-29 Lifemed Chronic Tenckhoff Peritoneal Catheter with Radiopaque Stripe and Two Attached Cuffs
10852250006014 - Lifemed Acute Tenckhoff Peritoneal Catheter2018-03-29 Acute Tenckhoff Peritoneal Catheter with Radiopaque Stripe and One Attached Cuff

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