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Nuwave

FDA UDI

Class I (US FDA UDI)

by Exceleron Medical, Llc

Identity

Trade Name
Nuwave FDA UDI
Generic Name
Home CPAP/BPAP washer-disinfector (ozone) FDA UDI
Device Name
NUWAVE with Small and Large Bag FDA UDI
Model / Reference
NW-004 FDA UDI
Description
NUWAVE with Small and Large Bag FDA UDI

Identifiers

Catalog Number
NW-004 FDA UDI
Primary DI / UDI-DI
00812970012033 FDA UDI
FDA Product Code
LRJ FDA UDI
GMDN Term
Home CPAP/BPAP washer-disinfector (ozone) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6890 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Home CPAP/BPAP washer-disinfector (ozone)

Nuwave by Exceleron Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home CPAP/BPAP washer-disinfector (ozone).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exceleron Medical, Llc

Sources (1)

  • FDA UDI 33dec4cc-1de9-45f9-af19-b5f01ca5c246 34 fields · synced May 31, 2026