FDA.report

Harmony Bath

Primary DI
05055982708968
Brand
Harmony Bath
Company
Arjohuntleigh AB
Model
AD31801US2000
Device description
Bath System - Har Sys23 SB P200+ Des
Published
2017-02-19
Public version status
Update
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

Product Codes

CodeName
ILJBath, hydro-massage

Product Code Classifications

CodeDeviceSpecialtyClass
ILJBath, Hydro-MassagePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055982708968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055982708968050559827089685055982708968

GMDN Terms

TermDefinition
Hydrotherapy bath/tankA bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility.

Sterilization Methods

Method

Regulatory Flags

DUNS number
355804758
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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