CareOne

FDA UDI

Class U (US FDA UDI)

by Ahold U.S.A., Inc.

Identity

Trade Name: CareOne FDA UDI
Generic Name: Mouthguard, reusable FDA UDI
Device Name: Rest Assured 2 Nite Protectors, Storage Case, Fitting Tray, Custom Fitting Instructions SQN54 FDA UDI
Model / Reference: 79002 FDA UDI
Description: Rest Assured 2 Nite Protectors, Storage Case, Fitting Tray, Custom Fitting Instructions SQN54 FDA UDI

Identifiers

Primary DI / UDI-DI: 00041520117946 FDA UDI
FDA Product Code: OBR FDA UDI
GMDN Term: Mouthguard, reusable FDA UDI

Classification

Device Class: U 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

Yes

FDA UDI

Convenience Kit

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

FDA UDI

Category: Mouthguard, reusable

CareOne by Ahold U.S.A., Inc. — Class U — 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 U	Pending data

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Manufacturer

Manufacturer: Ahold U.S.A., Inc.

Sources (1)

FDA UDI 56174af6-dd0e-4534-873b-925c1b9175f5 33 fields · synced Jun 8, 2026