Identity
- Trade Name
- NuVent™ FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- INFLATOR KIT 18INFKIT BALLOON FDA UDI
- Model / Reference
- 18INFKIT FDA UDI
- Description
- INFLATOR KIT 18INFKIT BALLOON FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000745080 FDA UDI
- 510(k) Number
- K152121 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Catheter/overtube balloon inflator, single-use
NuVent™ by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Catheter/overtube balloon inflator, single-use.
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- Merit Medical® — Merit Medical Systems, Inc. · Class II
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Cleared under the same submission
K152121 also covers:
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
- NuVent ™ — MEDTRONIC XOMED, INC.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI c68a9db1-10cb-4c18-9cc3-cc4bab77d357 35 fields · synced Jun 1, 2026