Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Inhalation therapy saline solution, isotonic FDA UDI
- Device Name
- HALYARD* Saline Vials for Closed Suction Catheters-Inhalation USP FDA UDI
- Model / Reference
- 93804 FDA UDI
- Description
- HALYARD* Saline Vials for Closed Suction Catheters-Inhalation USP FDA UDI
Identifiers
- Catalog Number
- 116 FDA UDI
- Primary DI / UDI-DI
- 20680651938040 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Inhalation therapy saline solution, isotonic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Inhalation therapy saline solution, isotonic
Halyard by Avanos Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inhalation therapy saline solution, isotonic.
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Sodium Chloride Inhalation Solution, USP, 0.9%-3mL — LIFESTAR PHARMA LLC · Class II
- Sodium Chloride Inhalation Solution, USP 0.9% — Nephron Pharmaceuticals Corp. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 5f071363-a2aa-4c86-ba31-9fca5bc7f537 35 fields · synced Jun 9, 2026