EcoLite, pediatric, medium concentration oxygen mask

FDA UDI

Class I (US FDA UDI)

by Intersurgical Incorporated

Identity

Trade Name: EcoLite, pediatric, medium concentration oxygen mask FDA UDI
Generic Name: Rebreathing oxygen face mask FDA UDI
Device Name: Intersurgical EcoLite, pediatric, medium concentration oxygen mask with universal connector tube, 1.8m FDA UDI
Model / Reference: 11906100 FDA UDI
Description: Intersurgical EcoLite, pediatric, medium concentration oxygen mask with universal connector tube, 1.8m FDA UDI

Identifiers

Primary DI / UDI-DI: 00816472021906 FDA UDI
FDA Product Code: BYG FDA UDI
GMDN Term: Rebreathing oxygen face mask FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5580 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Rebreathing oxygen face mask

EcoLite, pediatric, medium concentration oxygen mask by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Intersurgical Incorporated

Sources (1)

FDA UDI afb3e601-af84-47b7-88c5-8798321e0ad2 34 fields · synced May 30, 2026