FDA.reportPublic FDA data

Nuwave

Primary DI
00812970012002
Brand
Nuwave
Company
EXCELERON MEDICAL, INC.
Model
NW-001
Catalog number
NW-001
Device description
NUWAVE Generator
Published
2020-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LRJDisinfectant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812970012002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812970012002008129700120028129700120020812970012002

GMDN Terms#

Term, Definition table
TermDefinition
Home CPAP/BPAP washer/disinfectorA portable, electrically-powered device designed for the cleaning/disinfection of home positive airway pressure ventilation units (i.e., home CPAP unit, home BPAP unit) and/or masks (e.g., CPAP/BPAP oral mask) using ozone gas as the disinfecting agent. It is a small desktop unit with controls and an integrated ozone generator. It is intended for use in the home but may also be used in healthcare facilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825179992
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819989011576Thermalite Heated CPAP TubeCTUB-06H15DS2025-01-10
00812970012019NuwaveNW-002NW-0022020-09-23
00812970012026NuwaveNW-003NW-0032020-09-23
00812970012033NuwaveNW-004NW-0042020-09-23
00812970012040NuwaveUSB-PWR-ADPT-ULUSB-PWR-ADPT-UL2020-09-23
00812970012057NuwaveUSB-PWR-CORDUSB-PWR-CORD2020-09-23
00812970012064NuwaveUSB-PWR-ADPT-KITUSB-PWR-ADPT-KIT2020-09-23
00812970012071NuwaveNUWAVE-BG-SMNUWAVE-BG-SM2020-09-23
00812970012088NuwaveNUWAVE-BG-LGNUWAVE-BG-LG2020-09-23
00812970012095NuwaveCO-001CO-0012020-09-23
00812970012101NuwaveCO-001-KTCO-001-KT2020-09-23
00819989011187CPAP TubingCTUB-018-12021-05-24
00819989011002CPAP TubingCTUB-010-12020-09-24
00819989011026CPAP TubingCTUB-06S-12020-09-23
00819989011040CPAP TubingCTUB-060-12020-09-23
00819989011064CPAP TubingCTUB-080-12020-09-23
00819989011088CPAP TubingCTUB-090-12020-09-23
00819989011101CPAP TubingCTUB-100-12020-09-23
00819989011125CPAP TubingCPAP-TUBE-6FT-SPL-12020-09-23
00819989011149CPAP TubingCTUB-020-12020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344029317MEDLINEMEDLINE INDUSTRIES, INC.LRJ2026-04-27
04039239075462Citric Acid 50%B. BRAUN MEDICAL INC.LRJ2026-04-03
04039239075479Citric Acid 50%B. BRAUN MEDICAL INC.LRJ2026-04-03
00884392008420Safety 1stDOREL JUVENILE GROUP, INC.LRJ2025-12-15
10197344169085MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
20197344169082MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
00850080488072flysoundShenzhen Flysounds Medical Technology Co.,Ltd.LRJ2025-11-14
H816PSC050Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantMicroCare, LLCLRJ2025-10-23
08859335502220POSE HEALTH CARE LIMITED POSE HEALTH CARE LIMITEDLRJ2025-09-05
00615375013458CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00615375013472CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013455CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013479CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00815027010303DALTON WET WIPEDALTON MEDICAL CORPORATIONLRJ2025-05-15
00025469093455Ecolab Bleach Disinfectant WipeEcolab Inc.LRJ2025-05-09
00850065253244LIVE TULA Alcohol Pads 1.0 (100pcs/box)TULA HEALTH, INC.LRJ2025-03-18
06976301910710YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910727YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910734YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910741YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910758YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910765YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910772YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910789YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910796YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
10197344017683MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
10197344017690MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28