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Roscoe

FDA UDI

Class I (US FDA UDI)

by Compass Health Brands Corp.

Identity

Trade Name
ROSCOE FDA UDI
Generic Name
CPAP/BPAP nasal mask, reusable FDA UDI
Device Name
Respironics-Style Deluxe Chinstrap, compare to 302425 FDA UDI
Model / Reference
70146 FDA UDI
Description
Respironics-Style Deluxe Chinstrap, compare to 302425 FDA UDI

Identifiers

Primary DI / UDI-DI
00092237609200 FDA UDI
FDA Product Code
BYG FDA UDI
GMDN Term
CPAP/BPAP nasal mask, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: CPAP/BPAP nasal mask, reusable

Roscoe by Compass Health Brands Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CPAP/BPAP nasal mask, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compass Health Brands Corp.

Sources (1)

  • FDA UDI 55f9041b-9bb1-44ea-a440-51f52919630f 34 fields · synced May 30, 2026