Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Vascular access device flush/disinfection tool FDA UDI
- Device Name
- 48651 HYH,PREFILLSYR,SALINE,CLEAR,5ML,480 FDA UDI
- Model / Reference
- 48651 FDA UDI
- Description
- 48651 HYH,PREFILLSYR,SALINE,CLEAR,5ML,480 FDA UDI
Identifiers
- Catalog Number
- 48651 FDA UDI
- Primary DI / UDI-DI
- 10680651486513 FDA UDI
- 510(k) Number
- K183473 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Vascular access device flush/disinfection tool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular access device flush/disinfection tool
Halyard by O&M Halyard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183473 also covers:
- AMSafe® Pre-Filled Normal Saline Flush Syringe — AMSINO INTERNATIONAL, INC.
- AMSafe® Pre-Filled Normal Saline Flush Syringe — AMSINO INTERNATIONAL, INC.
- AMSafe® Pre-Filled Normal Saline Flush Syringe — AMSINO INTERNATIONAL, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- O&M Halyard, Inc.
Sources (1)
- FDA UDI a7debdc2-c5fe-41da-a642-75e29f9ec338 37 fields · synced May 29, 2026