FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756749428
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
HD-395-8000
Catalog number
HD-395-8000
Device description
RECTANGULAR BASIN - 8000CC
Published
2021-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNYBASIN, EMESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756749423PackageGS150In Commercial Distribution
00749756749428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975674942350749756749423
00749756749428007497567494287497567494280749756749428

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose bowl, single-useA portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This disposable device will typically be incinerated along with its contents if used for waste. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00661392012752LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392037977LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392053823LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392055063LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
10198956137714CARDINAL HEALTHCardinal Health 200, LLCFNY2025-08-28
16931918189192AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918190082AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918129310AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918140827AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918145464AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918146843Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
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00661392008083LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
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00661392045330LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392027664LSL HEALTHCARELSL Industries, LLCFNY2025-05-15
00661392004627LSL HEALTHCARELSL Industries, LLCFNY2025-04-22
10198956044890CARDINAL HEALTHCardinal Health 200, LLCFNY2025-04-03
10197106833780CARDINAL HEALTHCardinal Health 200, LLCFNY2024-12-31
10840330701355ProCureTwin Med, LLCFNY2024-11-14
10840330701362ProCureTwin Med, LLCFNY2024-11-14