FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756104395
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
8726-50
Catalog number
8726-50
Device description
CHILL-N-WRAP ICE BAG
Published
2021-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYRBAG, ICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYRBag, IceGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756104390PackageGS110In Commercial Distribution
00749756104395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975610439050749756104390
00749756104395007497561043957497561043950749756104395

GMDN Terms#

Term, Definition table
TermDefinition
Ice bagA flexible container (a bag) designed to be filled with ice to provide dry cold therapy to a limited external surface area of the body. It is typically made of plastic or rubber materials with a detachable cap that can be threaded or fixed to the bag once it is filled with ice. It may include a holder or attachments to facilitate fixing or holding the device in place against the body surface of the patient. It can be used to alleviate pain and/or promote healing in minor injuries of the body, e.g., after minor surgery, bruises, tissue swelling, or for application around the neck or limbs. This is a reusable 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
00749756402699DeRoyal25-1104EU25-1104EU2026-07-22
00749756402705DeRoyal25-1104EUN25-1104EUN2026-07-22
00749756402750DeRoyal25-1401YEU25-1401YEU2026-07-22
00749756402767DeRoyal25-1403EU25-1403EU2026-07-22
00749756402781DeRoyal25-1702EU25-1702EU2026-07-22
00749756402798DeRoyal25-1702EUN25-1702EUN2026-07-22
00749756402910DeRoyal25-0403EUN25-0403EUN2026-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776101843Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101850Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101867Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101874Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101881Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101898Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101904Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101911Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101928Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101935Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101942Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101959Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101966Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101973Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101980Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101997Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102000Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102017Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102024Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102031Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102628Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102635Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102642Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102659Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102666Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102673Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102895Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102901Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102918Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102925Neotech CareNEOTECH CARE INC.KYR2026-07-23