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Halyard

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name
Halyard FDA UDI
Generic Name
Epidural anaesthesia set, non-medicated FDA UDI
Device Name
N383A08 HYH,HUST,EPINDL,-,-,25 FDA UDI
Model / Reference
46784 FDA UDI
Description
N383A08 HYH,HUST,EPINDL,-,-,25 FDA UDI

Identifiers

Catalog Number
N383A08 FDA UDI
Primary DI / UDI-DI
10680651467840 FDA UDI
510(k) Number
K000495 FDA UDI
FDA Product Code
BSP FDA UDI
GMDN Term
Epidural anaesthesia set, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5150 FDA UDI
Commercial Distribution
Not 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

Halyard by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K000495 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avanos Medical, Inc.

Sources (1)

  • FDA UDI ba9b9624-6af6-4e1d-85ff-668be1c463f7 37 fields · synced Jun 9, 2026