FDA UDI
In Commercial Distribution
🇺🇸 United States
"X" SERIES PD CATHETER"X" SERIES PD CATHETER
DI: 00884908144123
·
Model: DTBC
·
Medical Components, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- "X" SERIES PD CATHETER"X" SERIES PD CATHETER
- Primary DI
- 00884908144123
- Version / Model
- DTBC
- Catalog Number
- DTBC
- Company Name
- Medical Components, Inc.
- Labeler DUNS
- 038000253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-23
- Public Version
- 1
- Public Version Date
- 2019-09-02
- Public Version Status
- New
- Public Device Record Key
- e3d1870a-cf5b-44a7-940f-8d256d02e7f0
Device Description
TITANIUM BARBED CONNECTORTITANIU
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FJS | Catheter, peritoneal, long-term indwelling | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47085 | Peritoneal dialysis catheter, acute/chronic | 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, and capable of being utilized for acute and chronic peritoneal dialysis. It may be surgically or endoscopically implanted, percutaneously, for long-term use; or percutaneously inserted for one-session dialysis. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30884908144124 | GS1 | inner box | 50 | In Commercial Distribution | |
| Primary | 00884908144123 | GS1 | ||||
| Package | 50884908144128 | GS1 | box | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(215)256-4201
- [email protected]