FDA.report

DeRoyal

Primary DI
00749756808507
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
M2200-CCP
Catalog number
M2200-CCP
Device description
Sensor Pad, Fall Alarm
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

Related Records

Contact Domains

Product Codes

CodeName
KMIMONITOR, BED PATIENT

Product Code Classifications

CodeDeviceSpecialtyClass
KMIMonitor, Bed PatientGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756808507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756808507007497568085077497568085070749756808507

GMDN Terms

TermDefinition
Bed/chair occupant movement sensorAn electrically-powered electronic sensing pad (pressure- or mechanical vibration-sensing) designed to be placed under a bed and/or chair occupant to detect and/or measure occupant movement related to activities such as sleep, wakefulness, and/or bed/chair exit. Some types are able to detect in addition occupant respiration and heart rates; and some types function with an alarm/alert/notification system to indicate unattended occupant attempt to vacate bed/chair.

Sterilization Methods

Method

Contacts

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
true
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 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

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10618125192325POSEYTIDI PRODUCTS, LLCKMI2025-12-04
00840828195416UNDER BED LIGHT CONTROLLER ASSEMBLYCURBELL MEDICAL PRODUCTS, INC.KMI2025-11-25
00840948103339Securitas HealthcareSecuritas Healthcare LLCKMI2025-09-26
00840948103346Securitas HealthcareSecuritas Healthcare LLCKMI2025-09-26
00860007550263Cubby BedsSensory Medical, Inc.KMI2025-01-31
20080196373236MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
40080196750116MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
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30023601033049CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.KMI2024-09-30
30023601033056CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.KMI2024-09-30
00840828192712UNDER BED LIGHT CONTROLLER ASSEMBLYCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-22
10197344103744MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-07-22
00840828192132UNI CHAIR SHORT-TERM-SNAP PADCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-19
10840828192146UNI BED SHORT-TERM-SNAP PADCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-19
04719873790050BriteMED Technology Inc.BRITEMED TECHNOLOGY INC.KMI2024-06-04
00850064651034Bed4Foresite Healthcare, LLCKMI2024-05-24
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