FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756391844
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
M70-500S
Catalog number
M70-500S
Device description
Turning and Positioning System
Published
2023-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMRDEVICE, TRANSFER, PATIENT, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756391844PackageGS110In Commercial Distribution
00749756391849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975639184450749756391844
00749756391849007497563918497497563918490749756391849

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer/turning sheetA manual device in the form of a sturdy sheet intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816317024499HoverMatt Lateral Transfer MatRENU MEDICAL, INCFMR2026-09-21
00860012736034Prism Lift Seated SlingPrism Pacific Industries LLCFMR2026-08-27
00860012736072Prism Lift Seated SlingPrism Pacific Industries LLCFMR2026-08-27
00860012736089Prism Lift Seated SlingPrism Pacific Industries LLCFMR2026-08-27
00860015694775Prism SlidePrism Pacific Industries LLCFMR2026-08-27
00860015694782Prism SlidePrism Pacific Industries LLCFMR2026-08-27
00199536930308BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930315BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930322BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930339BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930346BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
06973717276928GARVEEFoshan Dahao Medical Technology Co., Ltd.FMR2026-07-29
15059441537295AIRPALArjohuntleigh ABFMR2026-03-23
15059441537301AIRPALArjohuntleigh ABFMR2026-03-23
15059441537318AIRPALArjohuntleigh ABFMR2026-03-23
15059441537325AIRPALArjohuntleigh ABFMR2026-03-23
15059441537332AIRPALArjohuntleigh ABFMR2026-03-23
15059441537349AIRPALArjohuntleigh ABFMR2026-03-23
00810113682730ManaSlideManamed, Inc.FMR2025-11-25
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
0078755104129340649 Air-Assist +XODUS MEDICAL, INC.FMR2025-10-24
0078755104130940650 Air-Assist EXTXODUS MEDICAL, INC.FMR2025-10-24
10197344161249MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-07-11
20197344154958MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-04-23
10193489021141MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-02-14
0078755104000540685 Air Assist Power Lift - 120VACXODUS MEDICAL, INC.FMR2025-02-04
0078755104074640999 Air Assist Power Lift - 220VACXODUS MEDICAL, INC.FMR2025-02-04
10193489000658MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-01-03
10603354130200BAMEHOB INCFMR2024-09-12