FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MAHURKAR
DI: 20884521058375
·
Model: 8888135139
·
Mozarc Medical US LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MAHURKAR
- Primary DI
- 20884521058375
- Version / Model
- 8888135139
- Company Name
- Mozarc Medical US LLC
- Labeler DUNS
- 118997146
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 13
- Public Version Date
- 2025-04-29
- Public Version Status
- Update
- Public Device Record Key
- f4baed9f-3e3d-4cc4-897b-e7127f03ffe1
- Distribution End Date
- 2024-04-02
Device Description
Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC Components
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| MPB | Catheter, Hemodialysis, Non-Implanted | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46979 | Double-lumen haemodialysis catheter, nonimplantable | A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein 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 and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20884521058375 | GS1 | ||||
| Package | 10884521519527 | GS1 | PACK_OR_INNER_PACK | 15 | Not in Commercial Distribution | 2024-04-02 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030209 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 13.5 | French | |
| Length | 13.5 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit