FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MEDCOMP TESIO CATHETERSMEDCOMP TESIO CATHETERS
DI: 00884908141269
·
Model: DBFS-6CTT
·
Medical Components, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MEDCOMP TESIO CATHETERSMEDCOMP TESIO CATHETERS
- Primary DI
- 00884908141269
- Version / Model
- DBFS-6CTT
- Catalog Number
- DBFS-6CTT
- Company Name
- Medical Components, Inc.
- Labeler DUNS
- 038000253
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-14
- Public Version
- 3
- Public Version Date
- 2023-03-28
- Public Version Status
- Update
- Public Device Record Key
- 3d9c519f-5ab5-4549-8d5a-5fa5b459a6c4
- Distribution End Date
- 2023-03-15
Device Description
10F BIO-FLEX®TESIO® CATHETERS W/CUTTING TROCARSCATHE (ARTERIAL CUFF-18.2CM FROM(ARTER TIP) (VENOUS CUFF-21.2CMTIP) (VE FROM TIP)FROM TIP)
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 |
|---|---|---|---|---|
| MSD | Catheter, hemodialysis, implanted | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37278 | Double-lumen haemodialysis catheter, implantable | An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50884908141264 | GS1 | box | 5 | Not in Commercial Distribution | 2023-03-15 |
| Primary | 00884908141269 | GS1 |
Customer Contacts
- Phone
- +1(215)256-4201
- [email protected]