FDA.reportPublic FDA data

Lifemed Lifecoil Chronic Peritoneal Catheter

Primary DI
10852250006021
Brand
Lifemed Lifecoil Chronic Peritoneal Catheter
Company
LIFEMED OF CALIFORNIA
Model
PD6101
Catalog number
PD6101
Device description
Lifecoil Chronic Peritoneal Catheter with Radiopaque Stripe and Two Attached Cuffs
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
FKXSystem, Peritoneal, Automatic Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKXSystem, Peritoneal, Automatic DeliveryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852250006021PackageGS12In Commercial Distribution
00852250006024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085225000602110852250006021
00852250006024008522500060248522500060240852250006024

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis catheter, chronicA 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.

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
false
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
10852250006014Lifemed Acute Tenckhoff Peritoneal CatheterPD3103PD31032015-10-06
00852250006079Lifemed Pediatric Acute Tenckhoff Peritoneal CatheterPD4103PD41032015-10-06

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Primary DI, Brand, Company table
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00840861102709LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
00840861102716LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
10840861102706LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
10840861102713LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
00840861102280VersiPDFresenius Usa, Inc.FKX2023-08-01
00840861102211VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102228VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102235VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102617VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102198VersiPDFresenius Usa, Inc.FKX2023-02-14
10840861102218VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
10840861102225VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
10840861102232VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102297VersiPDFresenius Usa, Inc.FKX2023-02-14
10840861102614VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00860006810238CloudCath Connect - Patient Monitoring SoftwareGastroklenz Inc.FKX2022-08-17
00860006810245CloudCath Drain Set - Fresenius ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810207CloudCath Drain Set - Baxter ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810269CloudCath Drain Set - Fresenius ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810283CloudCath Sensor (Sensing Hardware)Gastroklenz Inc.FKX2022-08-05
00860006810214CloudCath Sensor (Sensing Hardware)Gastroklenz Inc.FKX2022-08-05
00884450462751Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-10-22
00884450462775Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-10-22
10884450462758Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-10-22
10884450462772Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-10-22
00884450462782Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-06-03