Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Subcutaneous tunneller, single-use FDA UDI
- Device Name
- HALYARD* ON-Q* Disposable Fluid Tunnelers & Sheaths 16 GA x 8 in FDA UDI
- Model / Reference
- 13546 FDA UDI
- Description
- HALYARD* ON-Q* Disposable Fluid Tunnelers & Sheaths 16 GA x 8 in FDA UDI
Identifiers
- Catalog Number
- FT16X8 FDA UDI
- Primary DI / UDI-DI
- 10680651135466 FDA UDI
- 510(k) Number
- K063234 FDA UDI
- FDA Product Code
- MEB FDA UDI
- GMDN Term
- Subcutaneous tunneller, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Subcutaneous tunneller, single-use
Halyard by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subcutaneous tunneller, single-use.
- AESCULAP — AESCULAP, INC. · Class I
- PMT® CORPORATION — Pmt Corp. · Class I
- Mainstay Tunneler — MAINSTAY MEDICAL LIMITED · Class III
- Argyle — Mozarc Medical US LLC · Class II
- Natus® — Natus Medical Incorporated · Class I
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- Natus® — Natus Medical Incorporated · Class I
Cleared under the same submission
K063234 also covers:
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI c053e6df-762e-44c1-9835-38ca1403746e 36 fields · synced Jun 9, 2026