FDA.report

LUMEX

Primary DI
M3687108A0
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
7108A
Catalog number
7108A
Device description
COMMODE FOLDING STEEL
Published
2021-08-12
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
M3687108A1PrimaryHIBCC0
M3687108A0Unit of UseHIBCC0

GMDN Terms

TermDefinition
CommodeA special kind of chair with a built-in receptacle for toileting away from a bathroom or fixed toilet and is designed for persons with a disability. Included in the GMDN code are sanichairs and commode chairs used for showering. It may or may not be supplied with wheels (castors).

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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M36823452C1GRAHAM FIELD2345-2C 2026-02-20
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M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20
M36823562X1GRAHAM FIELD2356-2X 2026-02-20
M36823572A1GRAHAM FIELD2357-2A 2026-02-20
M3682360A1GRAHAM FIELD2360A 2026-02-20
M3682362X2GRAHAM FIELD2362X2026-02-20
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M368H0678972HAUSTEDH0678972025-10-31
M368ALX361AMERILUXALX362025-12-11
M368ALX421AMERILUXALX422025-12-11

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