Identity
- Trade Name
- INTRODUCER SET FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- VGCTR03 INTRODUCER SET FDA UDI
- Model / Reference
- VGCTR03 FDA UDI
- Description
- VGCTR03 INTRODUCER SET FDA UDI
Identifiers
- Catalog Number
- VGCTR03 FDA UDI
- Primary DI / UDI-DI
- 00850004162125 FDA UDI
- 510(k) Number
- K180178 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Introducer Set by Valflux Group, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular catheter introduction set, nonimplantable.
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- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
Cleared under the same submission
K180178 also covers:
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INTRODUCER SET — VALFLUX GROUP, LLC
- INTRODUCER SET — VALFLUX GROUP, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Valflux Group, Llc
Sources (1)
- FDA UDI 1f976e29-6cea-4a5f-a21e-2d15f2e4012b 36 fields · synced May 30, 2026