FDA.report

LUMEX

Primary DI
M3687931RA0
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
7931RA
Catalog number
7931RA
Device description
BATH SEAT W/ARMS RETAIL
Published
2021-08-13
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
INNChair, Adjustable, Mechanical

Product Code Classifications

CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M3687931RA1PrimaryHIBCC0
M3687931RA0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Bath back rest/seatA device designed to support the back, and sometimes buttocks, of a patient (usually an adult) who is bathing in a bath (usually while being attended/assisted) to enable the patient to sit in an upright, and sometimes elevated, position in the bath. The patient is typically disabled, infirm, or undergoing medical treatment and cannot sit normally in a bath. The device may be a back rest only or a seat with an incorporated back rest, typically made of water-resistant or waterproof materials; it may be laid across the rim of the bath or secured to the bath. The device may be used in a hospital, institution, or home.

Sterilization Methods

Method

Contacts

PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags

DUNS number
132016168
Device count
4
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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