FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756973521
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
M70-500TS
Catalog number
M70-500TS
Device description
Turning and Positioning System
Published
2021-08-03
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
50749756973521PackageGS110In Commercial Distribution
00749756973526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975697352150749756973521
00749756973526007497569735267497569735260749756973526

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(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
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
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05059441537298AIRPALArjohuntleigh ABFMR2026-03-23
05059441537304AIRPALArjohuntleigh ABFMR2026-03-23
05059441537311AIRPALArjohuntleigh ABFMR2026-03-23
05059441537328AIRPALArjohuntleigh ABFMR2026-03-23
05059441537335AIRPALArjohuntleigh ABFMR2026-03-23
05059441537342AIRPALArjohuntleigh ABFMR2026-03-23
00850056748360APLS Thermal WrapINTEGRATED MEDCRAFT LLCFMR2026-02-16
07333350703745Tortoise™ Turning & positioning systemMölnlycke Health Care ABFMR2026-02-11
07333350636012Tortoise™ Turning & positioning systemMölnlycke Health Care ABFMR2026-02-11
07613327681710N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.FMR2026-02-11
06975575170103YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-02-10
06975575170028YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170035YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170042YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170059YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170097YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
00199284069657Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00199284569546Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00199284790896Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970710Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970727Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970734Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970741Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970758Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970765Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970772Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970796Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860015268808Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860015268815Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00850056748292FORWARD APLS Litter GuardINTEGRATED MEDCRAFT LLCFMR2026-01-15