FDA.report

FITRIGHT

Primary DI
20193489082736
Brand
FITRIGHT
Company
MEDLINE INDUSTRIES, INC.
Model
MSACHAR01
Catalog number
MSACHAR01
Device description
CHARGER, FITRIGHT CONNECT
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KPNAlarm, conditioned response enuresis

Product Code Classifications

CodeDeviceSpecialtyClass
KPNAlarm, Conditioned Response EnuresisGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489082736PackageGS110In Commercial Distribution
10193489082739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348908273620193489082736
1019348908273910193489082739

GMDN Terms

TermDefinition
Incontinence sensor/alarmA electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
true
Sterilization required before use
false

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