FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756139243
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
72-3103-S
Device description
Neonatal Blood Pressure Cuff,Disposable
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXQblood pressure cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756139248PackageGS110In Commercial Distribution
00749756139243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975613924850749756139248
00749756139243007497561392437497561392430749756139243

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, single-useA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. 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
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
06931973438504CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438511CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438528CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973454689CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456737CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456744CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456751CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456768CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456775CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456782CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456799CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456805CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456812CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456829CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456836CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456843CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456850CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456867CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456874CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456881CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456898CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456904CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456911CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456928CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456935CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456942CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456959CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456966CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456973CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456980CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09