One Mask™ Oxygen Mask

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref OM001

by Amsino International, Inc.

Identity

Trade Name: ROLLINS 7 Oxygen Mask EUDAMED
One Mask™ Oxygen Mask FDA UDI
Generic Name: Nebulizing system delivery set, single-use FDA UDI
Device Name: Oxygen Mask EUDAMED
One Mask™ Oxygen Mask Mask, Adapter, 79" (200cm) Oxygen Tubing w/Label FDA UDI
Model / Reference: OM001 EUDAMED
1 FDA UDI
Description: One Mask™ Oxygen Mask Mask, Adapter, 79" (200cm) Oxygen Tubing w/Label FDA UDI

Identifiers

Catalog Number: OM001 FDA UDI
Primary DI / UDI-DI: 10704411013129 EUDAMED
10704411000426 FDA UDI
Basic UDI-DI: B-10704411013129 EUDAMED
FDA Product Code: CAF FDA UDI
EMDN Code: R03010201 AIR/OXYGEN MASKS EUDAMED
GMDN Term: Nebulizing system delivery set, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 868.5630 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Nebulizing system delivery set, single-use

One Mask™ Oxygen Mask by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Amsino International, Inc.

Sources (2)

FDA UDI bc2fca43-e49f-4250-a3c3-8b7644b45934 34 fields · synced Jul 14, 2026
EUDAMED 5e6cf7e3-db35-41cc-807f-89a8c5a07955 61 fields · synced Jul 14, 2026