FDA.report

N/A

Primary DI
57613327503277
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
73030
Catalog number
73030
Device description
Stanley Chair Sensormat Pad, 14 Days, 8' Long Cord
Published
2019-09-13
Public version status
Update
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
57613327503277PackageGS110In Commercial Distribution
07613327503272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
5761332750327757613327503277
07613327503272076133275032727613327503272

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.

Device Sizes

TypeValueUnit
Length8Feet

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags

DUNS number
020198912
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

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