Ferno2

FDA UDI

Class I (US FDA UDI)

by Spiracle Technology

Identity

Trade Name: FERNO2 FDA UDI
Generic Name: Resuscitator face mask, reusable FDA UDI
Device Name: Silicone Cuffed Mask: Size 4 FDA UDI
Model / Reference: T50550-04 FDA UDI
Description: Silicone Cuffed Mask: Size 4 FDA UDI

Identifiers

Primary DI / UDI-DI: 00814940020871 FDA UDI
FDA Product Code: KGB FDA UDI
GMDN Term: Resuscitator face mask, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5570 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Resuscitator face mask, reusable

Ferno2 by Spiracle Technology — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Resuscitator face mask, reusable.

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HUDSON RCI — TELEFLEX INCORPORATED · Class I
Silicone Face Mask — Ambu A/S · Class I
Rescuer Silicone Resuscitation Mask (#5 Adult) — B.L.S. Systems Limited · Class I
Rescuer Silicone Resuscitation Mask (#4 Adult) — B.L.S. Systems Limited · Class I
HUDSON RCI — TELEFLEX INCORPORATED · Class I
HUDSON RCI — TELEFLEX INCORPORATED · 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: Spiracle Technology

Sources (1)

FDA UDI 72b51768-bd1a-4972-8cef-4bfdfddc629d 33 fields · synced May 30, 2026