FDA.reportPublic FDA data

Lifemed Acute Tenckhoff Peritoneal Catheter

Primary DI
10852250006014
Brand
Lifemed Acute Tenckhoff Peritoneal Catheter
Company
LIFEMED OF CALIFORNIA
Model
PD3103
Catalog number
PD3103
Device description
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
OTC
false
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
10852250006014PackageGS12In Commercial Distribution
00852250006017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085225000601410852250006014
00852250006017008522500060178522500060170852250006017

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
Lumen/Inner Diameter2.66Millimeter

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10852250006021Lifemed Lifecoil Chronic Peritoneal CatheterPD6101PD61012015-10-06
00852250006079Lifemed Pediatric Acute Tenckhoff Peritoneal CatheterPD4103PD41032015-10-06

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
00852250006079Lifemed Pediatric Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06