FDA.reportPublic FDA data

Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter

Primary DI
00852250006079
Brand
Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter
Company
LIFEMED OF CALIFORNIA
Model
PD4103
Catalog number
PD4103
Device description
Pediatric Acute Tenckhoff Peritoneal Catheter with Radiopaque Stripe and One Attached Cuff
Published
2015-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKOCatheter, Peritoneal Dialysis, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKOCatheter, Peritoneal Dialysis, Single UseGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852250006076PackageGS12In Commercial Distribution
00852250006079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085225000607610852250006076
00852250006079008522500060798522500060790852250006079

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis catheter, acuteA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Centimeter
Lumen/Inner Diameter2.66Millimeter
Outer Diameter4.69Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-543-3633info@lifemedofcalifornia.com

Regulatory Flags#

DUNS number
152680815
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852250006093Lifemed Line ClampC4531C45312019-03-20
00852250006109Lifemed Coated Line ClampC4522C45222019-03-20
00852250006031Lifemed Tubing Recirculating SetB3109B31092015-10-06
00852250006048Lifemed Male to Male Luer AdapterB3109ZB3109Z2015-10-06
00852250006055Lifemed Low Volume Tubing SetB95-079-2B95-079-22015-10-06
00852250006062Lifemed 60 inch Monitor LineB1900B19002015-10-06
10852250006038Lifemed Tubing Recirculating SetB3109B31092015-10-06
20852250006042Lifemed Male to Male Luer AdapterB3109ZB3109Z2015-10-06
10852250006052Lifemed Low Volume Tubing SetB95-079-2B95-079-22015-10-06
10852250006069Lifemed 60 inch Monitor LineB1900B19002015-10-06
10852250006083Lifemed Cannula ClampC4516C45162015-10-13
00852250006000Lifemed Chronic Tenckhoff Peritoneal CatheterPD3101PD31012015-10-06
00852250006017Lifemed Acute Tenckhoff Peritoneal CatheterPD3103PD31032015-10-06
00852250006024Lifemed Lifecoil Chronic Peritoneal CatheterPD6101PD61012015-10-06
10852250006007Lifemed Chronic Tenckhoff Peritoneal CatheterPD3101PD31012015-10-06
10852250006014Lifemed Acute Tenckhoff Peritoneal CatheterPD3103PD31032015-10-06
10852250006021Lifemed Lifecoil Chronic Peritoneal CatheterPD6101PD61012015-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521811164RitusMozarc Medical US LLCFKO2026-04-20
10885403108327n/aCAREFUSION 2200, INCFKO2017-06-12
50885403108325n/aCAREFUSION 2200, INCFKO2017-06-12
10884521024281ArgyleMozarc Medical US LLCFKO2016-09-24
10884521024298ArgyleMozarc Medical US LLCFKO2016-09-24
10884521024311ArgyleMozarc Medical US LLCFKO2016-09-24
20884521024288ArgyleCovidien LPFKO2016-09-24
20884521024295ArgyleCovidien LPFKO2016-09-24
20884521024301ArgyleCovidien LPFKO2016-09-24
20884521024318ArgyleCovidien LPFKO2016-09-24
H67140005070DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005170DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005270DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005370DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005470DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005570DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005670DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
00898021000068Alcavis 50Angelini Pharma Inc.FKO2016-08-29
20898021000062Alcavis 50ANGELINI PHARMA INC.FKO2016-08-29
00884450170021Flex-Neck®Merit Medical Systems, Inc.FKO2015-10-30
10884450170028Flex-Neck®Merit Medical Systems, Inc.FKO2015-10-30
00852250006017Lifemed Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06
10852250006014Lifemed Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06