FDA.reportPublic FDA data

PERSONAL PULLSTRING MONITOR PM100 W/BATT

Primary DI
00840828161350
Brand
PERSONAL PULLSTRING MONITOR PM100 W/BATT
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
CSM-PM100
Catalog number
16185
Device description
PERSONAL PULLSTRING MONITOR PM100 W/BATT
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00840828161350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828161350008408281613508408281613500840828161350

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call system alarmAn electronic device intended to provide an audible sound and/or a visual display, typically coloured flashing lights or scrolling text, to notify a medical professional that (urgent) assistance is needed by a patient. It may be in the form of dome lights, basic visual display screens, and/or beeping devices which are triggered by manual or automatic alert activators (e.g., bedside push-button, ambulatory fall sensor, bed occupancy sensor) [not included]; it may function independently or as a component of a nurse call system via the healthcare facility hardwired or wireless network.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002357500mwinter@curbell.com

Regulatory Flags#

DUNS number
796452311
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828196178JUMPER,6",S102 TO 7 PIN DINJU06-626306542026-03-20
00840828187374SURE LOCK, ASSEMBLY, A34, BLUE LEVERSLC-4200-006277592023-01-09
00840828196109GEN4 PLUS, DIRECT ACCESS5C383U-Z10300008306042026-03-11
00840828196116GEN4 INTERACTIVE4G331E-0148798305822026-03-11
00840828196123RESPONDER 5, INTERACTIVE5I4112U-B64453A306142026-03-11
00840828196130RESPONDER 5, INTERACTIVE5I4112U-101471A306052026-03-11
00840828196147RESPONDER 5, INTERACTIVE5I4112U-500001A306082026-03-11
00840828196154RESPONDER 5, INTERACTIVE5I411U-F00001A306112026-03-11
00840828196161GEN4 INTERACTIVE414430U-0151049306152026-03-11
00840828196079GEN4 DIRECT ACCESS4C19NN-Z10200A305452026-03-04
00840828196086GEN4 DIRECT ACCESS4C19NN-Z10200C305462026-03-04
00840828196093RESPONDER 5, INTERACTIVE5I4112U-001462A306012026-03-04
00840828196000GEN4 INTERACTIVE43319FU-0143088305712026-03-03
00840828196017GEN4 INTERACTIVE4X331E-000503C305812026-03-03
00840828196024RESPONDER 5, INTERACTIVE5I41JU-363465A305862026-03-03
00840828196031GEN4 INTERACTIVE414370E-010346A305932026-03-03
00840828196048RESPONDER 5, INTERACTIVE5I41JU-363425A305942026-03-03
00840828196055GEN4 INTERACTIVE4M370E-Z749368305962026-03-03
00840828196062GEN4 INTERACTIVE4M370E-Z749448305982026-03-03
00840828195966ZEPHYR,800,10,PUFF,JERON 680GEB-19C0-203A-N305512026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850043155072Cubby BedsSensory Medical, Inc.KMI2026-03-16
00199874390529Nightwatch Bedroom ModuleLutso Inc.KMI2026-03-06
05000223503956LEAFSMITH & NEPHEW MEDICAL LIMITEDKMI2026-03-03
05000223503994LEAFSMITH & NEPHEW MEDICAL LIMITEDKMI2026-03-01
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
20193489001928MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-11-28
00840828193405SAFE MOBILITY LIGHT KIT,XMIT,PAD,PWR 8'CURBELL MEDICAL PRODUCTS, INC.KMI2024-11-08
10193489001648MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-11-08
00840948103285Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103292Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103308Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103315Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103322Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
20193489036630MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-10-25
00190676007653PoseyPOSEY PRODUCTS, LLCKMI2024-10-23
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
00850064651072Bed4Foresite Healthcare, LLCKMI2024-05-24