FDA.reportPublic FDA data

"BED PAD, WIRELESS, 14 DAY, 4""X30"""

Primary DI
00840828161596
Brand
"BED PAD, WIRELESS, 14 DAY, 4""X30"""
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
CSP-B14-NW4
Catalog number
19587
Device description
"BED PAD, WIRELESS, 14 DAY, 4""X30"""
Published
2019-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMIMonitor, Bed Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMIMonitor, Bed PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828161596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828161596008408281615968408281615960840828161596

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair occupancy sensorA battery-powered electronic pressure pad designed to be placed under a bed and/or chair occupant (e.g., a geriatric patient, an Alzheimer's disease or dementia patient, a person with a disability, or a wheelchair user) who is at risk of vacating the bed/chair unattended and potentially falling. It is intended to detect diminished body-weight pressure should the user attempt to vacate the bed/chair, and functions in conjunction with an audible alarm or nurse call/home alert system which will provide an alert signal for assistance.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002357500mwinter@curbell.com

Regulatory Flags#

DUNS number
796452311
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828196468RESPONDER 5, INTERACTIVE5I4112U-101463A307532026-05-27
00840828196475GEN4 INTERACTIVE412331U-0103018307602026-05-27
00840828196482GEN4 INTERACTIVE412331U-0105018307612026-05-27
00840828196499GEN4 INTERACTIVE412331U-0147018307622026-05-27
00840828196505GEN4 INTERACTIVE412331U-0147178307632026-05-27
00840828196512GEN4 INTERACTIVE412331U-0143018307642026-05-27
00840828196529GEN4 INTERACTIVE412331U-0147171307652026-05-27
00840828196536GEN4 INTERACTIVE412331U-0150018307662026-05-27
00840828196543GEN4 INTERACTIVE412331U-0145518307672026-05-27
00840828196550GEN4 INTERACTIVE412331U-0100008307682026-05-27
00840828196567GEN4 INTERACTIVE412331U-0100018307692026-05-27
00840828196574GEN4 INTERACTIVE412331U-0119018307702026-05-27
00840828196581GEN4 INTERACTIVE412331U-014701C307712026-05-27
00840828196598GEN4 INTERACTIVE412331U-0105011307722026-05-27
00840828196604GEN4 INTERACTIVE412331U-0153518307732026-05-27
00840828196611GEN4 INTERACTIVE412331U-015400C307742026-05-27
00840828196628GEN4 INTERACTIVE412331U-0155588307752026-05-27
00840828196635GEN4 INTERACTIVE412331U-0156518307762026-05-27
00840828196642GEN4 INTERACTIVE412331U-014717C307772026-05-27
00840828196659GEN4 INTERACTIVE412331U-014301C307782026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618125192328POSEYTIDI PRODUCTS, LLCKMI2025-12-04
00840828195348ANTI-SLIP, GRIP PAD FOR SENSOR PADS,10PKCURBELL MEDICAL PRODUCTS, INC.KMI2025-11-05
00840828195102FM UNDER-MATTERSS KIT-CORDEDCURBELL MEDICAL PRODUCTS, INC.KMI2025-09-10
00850064210163Central Hub CMSSibel Health Inc.KMI2025-03-27
00850064210194Central Hub SpeakerSibel Health Inc.KMI2025-03-27
00850064210002ANNE Chest Sensor KitSibel Health Inc.KMI2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.KMI2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.KMI2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.KMI2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.KMI2025-03-26
00850064210132ANNE View Patient MonitorSibel Health Inc.KMI2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.KMI2025-03-26
10080196373239MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
00080196750118MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
10193489001921MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-11-28
10193489036633MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-10-25
00023601033048CAREX HEALTH BRANDSDrive Devilbiss HealthcareKMI2024-09-30
00023601033055CAREX HEALTH BRANDSDrive Devilbiss HealthcareKMI2024-09-30
00840828192149UNI BED SHORT-TERM-SNAP PADCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-19
00618125191406PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191413PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191420PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191437PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191444PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191451PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191468PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191499PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191505PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191512PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191529PoseyTIDI PRODUCTS, LLCKMI2024-05-03