3100 Hfov

FDA UDI

Class III (US FDA UDI)

by Vyaire Medical, Inc.

Identity

Trade Name: 3100 HFOV FDA UDI
Generic Name: Medical device service rail clamp FDA UDI
Device Name: KIT, 3100 BLENDER BRACKET FDA UDI
Model / Reference: 26209-001 FDA UDI
Description: KIT, 3100 BLENDER BRACKET FDA UDI

Identifiers

Catalog Number: 26209-001 FDA UDI
Primary DI / UDI-DI: 10190752155213 FDA UDI
PMA Number: P890057 FDA UDI
FDA Product Code: LSZ FDA UDI
GMDN Term: Medical device service rail clamp FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical device service rail clamp

3100 Hfov by Vyaire Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical device service rail clamp.

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D130/D131 KIDS Arterial Filter — SORIN GROUP ITALIA SRL · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Bracket — LivaNova USA, Inc. · Class I
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
CAPIOX — Terumo Corp. · Class I

Cleared under the same submission

P890057 also covers:

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 III	Pending data

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Manufacturer

Manufacturer: Vyaire Medical, Inc.

Sources (1)

FDA UDI 2c464ee1-9ab6-47a2-9490-57120b2fb30c 36 fields · synced Jun 6, 2026