FDA.report

CHAIR PAD-CORDED-TIMED-18 MO-10X15-34"C

Primary DI
00840828174183
Brand
CHAIR PAD-CORDED-TIMED-18 MO-10X15-34"C
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
CSP-C18MO-TC10-34
Catalog number
24862
Device description
CHAIR PAD-CORDED-TIMED-18 MO-10X15-34"C
Published
2019-09-17
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

Related Records

Contact Domains

Product Codes

CodeName
KMIMonitor, Bed Patient

Product Code Classifications

CodeDeviceSpecialtyClass
KMIMonitor, Bed PatientGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840828174183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828174183008408281741838408281741830840828174183

GMDN Terms

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

Contacts

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
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00840828196024RESPONDER 5, INTERACTIVE5I41JU-363465A305862026-03-03
00840828196031GEN4 INTERACTIVE414370E-010346A305932026-03-03
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00840828196055GEN4 INTERACTIVE4M370E-Z749368305962026-03-03
00840828196062GEN4 INTERACTIVE4M370E-Z749448305982026-03-03
00840828195966ZEPHYR,800,10,PUFF,JERON 680GEB-19C0-203A-N305512026-02-11

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