FDA UDI
In Commercial Distribution
🇺🇸 United States
Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter
DI: 00852250006079
·
Model: PD4103
·
LIFEMED OF CALIFORNIA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lifemed Pediatric Acute Tenckhoff Peritoneal Catheter
- Primary DI
- 00852250006079
- Version / Model
- PD4103
- Catalog Number
- PD4103
- Company Name
- LIFEMED OF CALIFORNIA
- Labeler DUNS
- 152680815
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-06
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f18968bd-5f50-4341-b29d-bc9d7e55c7a1
Device Description
Pediatric Acute Tenckhoff Peritoneal Catheter with Radiopaque Stripe and One Attached Cuff
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FKO | Catheter, Peritoneal Dialysis, Single Use | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47084 | Peritoneal dialysis catheter, acute | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852250006079 | GS1 | ||||
| Package | 10852250006076 | GS1 | box | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-543-3633
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 28 | Centimeter | |
| Outer Diameter | 4.69 | Millimeter | |
| Lumen/Inner Diameter | 2.66 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius