Identity
- Trade Name
- NIH™ Cardio-Marker FDA UDI
- Generic Name
- Angiographic catheter, single-use FDA UDI
- Device Name
- WVN CATH 010011 6F 5PK 80 PEDI NIH FDA UDI
- Model / Reference
- 010011 FDA UDI
- Description
- WVN CATH 010011 6F 5PK 80 PEDI NIH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000200015 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Angiographic catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 6.0 French FDA UDILumen/Inner Diameter — 1.219 Millimeter FDA UDILength — 80.0 Centimeter FDA UDI
NIH™ Cardio-Marker by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 2892b725-cd3e-4ba5-83e7-83048cb83c2b 37 fields · synced May 31, 2026