Halyard

FDA UDI

Class I (US FDA UDI)

by O&M Halyard, Inc.

Identity

Trade Name: Halyard FDA UDI
Generic Name: Wrist orthosis FDA UDI
Device Name: HALYARD* I.V. Therapy HAND-AID* Arterial Wrist Support, Pediatric FDA UDI
Model / Reference: 29990 FDA UDI
Description: HALYARD* I.V. Therapy HAND-AID* Arterial Wrist Support, Pediatric FDA UDI

Identifiers

Catalog Number: 29990 FDA UDI
Primary DI / UDI-DI: 20680651299905 FDA UDI
FDA Product Code: ILH FDA UDI
GMDN Term: Wrist orthosis FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Wrist orthosis

Halyard by O&M Halyard, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Wrist orthosis.

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MEDI — MEDI MANUFACTURING, INC. · Class I
PROCARE — DJO, LLC · Class I
Push Sports — Nea International B.V. · Class I
Wrist Lacer — MEDICAL SPECIALTIES INCORPORATED · Class I
MEDI — MEDI MANUFACTURING, INC. · Class I

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

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Manufacturer

Manufacturer: O&M Halyard, Inc.

Sources (1)

FDA UDI cbe69553-af42-45f5-ab2a-9c587efa0277 35 fields · synced Jun 1, 2026