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Halyard

FDA UDI

Class I (US FDA UDI)

by Avanos Medical, Inc.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 5f071363-a2aa-4c86-ba31-9fca5bc7f537 35 fields · synced Jun 9, 2026