FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756387903
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
NP-0507P
Catalog number
NP-0507P
Device description
Prospera PRO NPWT Kit w/ Prospera Propel Technology
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMPnegative pressure wound therapy Powered suction pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756387908PackageGS110In Commercial Distribution
00749756387903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975638790850749756387908
00749756387903007497563879037497563879030749756387903

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system dressing setA collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(865)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08
00749756402682DeRoyal25-0802EU25-0802EU2026-07-08
00749756402712DeRoyal25-1108EU25-1108EU2026-07-08
00749756402729DeRoyal25-1108EUN25-1108EUN2026-07-08
00749756402736DeRoyal25-1401EU25-1401EU2026-07-08
00749756402743DeRoyal25-1401EUN25-1401EUN2026-07-08
00749756402774DeRoyal25-1403EUN25-1403EUN2026-07-08
00749756402538DeRoyal25-0101EUN25-0101EUN2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117350984Durma+ Flexible Suction Bell, With TubingDynarex CorporationOMP2026-06-22
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00849405002796Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002673Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002680Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002697Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002710Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002727Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
08718104890947Endo-SPONGE PumpMeditop B.V.OMP2025-10-17
00197998028922Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998028946Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998032608Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998312267Solventum US LLCKCI USA, INC.OMP2025-07-29
10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14
07612367016940Invia Liberty Carrying CaseMedela AGOMP2024-10-11
07612367060509Invia Motion Carrying CaseMedela AGOMP2024-10-11
07612367038713Standard rail universal holderMedela AGOMP2024-06-03
00749756390194DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390200DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390217DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08