Identity
- Trade Name
- MAK-NV™ FDA UDI
- Generic Name
- Non-vascular catheter introduction set FDA UDI
- Model / Reference
- 00884450088838 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450088838 FDA UDI
- FDA Product Code
- GCB FDA UDI
- GMDN Term
- Non-vascular catheter introduction set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Non-vascular catheter introduction set
The MAK-NV device is a single-use, non-vascular catheter introduction set designed for the safe and effective insertion of needles and introducer sheaths into various body cavities and lumen, ensuring optimal patient outcomes. This device meets the high standards of Merit Medical Systems, Inc., a leading manufacturer of invasive devices.
Similar devices
Also classified as Non-vascular catheter introduction set.
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- Inrad — Inrad · Class II
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 8856c859-42d2-4fc7-a243-2fb44fd6cb99 33 fields · synced Jul 11, 2026