FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756376339
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
3778
Catalog number
3778
Device description
ReMuv Air Half Mat
Published
2021-09-14
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
50749756376339PackageGS110In Commercial Distribution
00749756376334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975637633950749756376339
00749756376334007497563763347497563763340749756376334

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer system, manualA wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance (i.e., without changing horizontal body position, lifting, rolling, or dragging). The device typically includes a patient-transfer mechanism (e.g., mechanical, hydraulic) easy to operate by an attendant with minimal physical effort. It is used in hospitals and other healthcare facilities to reduce injuries to both patients and staff while transferring non-ambulatory, comatose, or neurologically-injured patients between beds, tables, and/or stretchers.

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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

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Primary DI, Brand, Company table
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15059441537325AIRPALArjohuntleigh ABFMR2026-03-23
15059441537332AIRPALArjohuntleigh ABFMR2026-03-23
15059441537349AIRPALArjohuntleigh ABFMR2026-03-23
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0078755104129340649 Air-Assist +XODUS MEDICAL, INC.FMR2025-10-24
0078755104130940650 Air-Assist EXTXODUS MEDICAL, INC.FMR2025-10-24
00816299012569HoverMatt PROS Hovertech InternationalFMR2025-09-10
00816299012576HoverMatt PROS Hovertech InternationalFMR2025-09-10
00816299012781HoverMatt PROS Hovertech InternationalFMR2025-09-10
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
10603354130248BAMEHOB INCFMR2024-09-12
10603354130262BAMEHOB INCFMR2024-09-12
10603354130286BAMEHOB INCFMR2024-09-12
10603354130309BAMEHOB INCFMR2024-09-12
10603354130323BAMEHOB INCFMR2024-09-03
10603354130347BAMEHOB INCFMR2024-09-03
10603354130361BAMEHOB INCFMR2024-09-03
10603354130446BAMEHOB INCFMR2024-09-03
10603354130514BAMEHOB INCFMR2024-09-03