Primary Device ID | 00852250006079 |
NIH Device Record Key | f18968bd-5f50-4341-b29d-bc9d7e55c7a1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter |
Version Model Number | PD4103 |
Catalog Number | PD4103 |
Company DUNS | 152680815 |
Company Name | LIFEMED OF CALIFORNIA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 800-543-3633 |
info@lifemedofcalifornia.com |
Lumen/Inner Diameter | 2.66 Millimeter |
Lumen/Inner Diameter | 2.66 Millimeter |
Lumen/Inner Diameter | 2.66 Millimeter |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00852250006079 [Primary] |
GS1 | 10852250006076 [Package] Package: box [2 Units] In Commercial Distribution |
FKO | Catheter, Peritoneal Dialysis, Single Use |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-10-06 |
10852250006038 - Lifemed Tubing Recirculating Set | 2019-06-07 Tubing Recirculating Set |
20852250006042 - Lifemed Male to Male Luer Adapter | 2019-06-07 Male to Male Luer Adapter |
10852250006052 - Lifemed Low Volume Tubing Set | 2019-06-07 Low Volume Tubing Set |
10852250006069 - Lifemed 60 inch Monitor Line | 2019-06-07 60 inch (152 cm) Monitor Line |
00852250006093 - Lifemed Line Clamp | 2019-03-28 Nonsterile Line Clamp, single external use |
00852250006109 - Lifemed Coated Line Clamp | 2019-03-28 Nonsterile Coated Line Clamp, single external use |
10852250006007 - Lifemed Chronic Tenckhoff Peritoneal Catheter | 2018-03-29 Lifemed Chronic Tenckhoff Peritoneal Catheter with Radiopaque Stripe and Two Attached Cuffs |
10852250006014 - Lifemed Acute Tenckhoff Peritoneal Catheter | 2018-03-29 Acute Tenckhoff Peritoneal Catheter with Radiopaque Stripe and One Attached Cuff |