Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI
- Device Name
- Prefilled Syringe Saline Flush Intravenous 5ML PP Clear Not Made with Natural Rubber Latex Halyard FDA UDI
- Model / Reference
- SS005 FDA UDI
- Description
- Prefilled Syringe Saline Flush Intravenous 5ML PP Clear Not Made with Natural Rubber Latex Halyard FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632389764 FDA UDI
- 510(k) Number
- K150143 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial 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 catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Halyard by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial.
- BAL Flush Spritze 10ml DS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-fillefd flush syringe(B001-MY) — Jiangsu Embrace Science&Technology Development Co., Ltd. · Class IIa
- Burg Pharma — Jiangsu Caina Medical Co.,Ltd. · Class IIa
- BAL Flush Spritze 5ml SS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-Filled Saline Flush Syringe, Sterile, 5mL — Dynarex Corp. · Class II
- EASY FLUSH — SPM MEDICARE PVT, LTD. · Class IIb
- Prefilled Syringe with 0.9% Saline Solution — Poly Medicure Limited · Class IIb
- KLINION — Jiangsu Caina Medical Co.,Ltd. · Class IIa
Cleared under the same submission
K150143 also covers:
- COVIDIEN — NURSE ASSIST, INC.
- COVIDIEN — NURSE ASSIST, INC.
- COVIDIEN — NURSE ASSIST, INC.
- COVIDIEN — NURSE ASSIST, INC.
- COVIDIEN — NURSE ASSIST, INC.
- COVIDIEN — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, 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
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 826889c8-e74b-4bcb-9702-fde06d3ee5f7 34 fields · synced May 30, 2026