FDA.reportPublic FDA data

"Dynarex Bari + Max Bariatric HD Commode, Drop Arm, 26"""

Primary DI
00840117324572
Brand
"Dynarex Bari + Max Bariatric HD Commode, Drop Arm, 26"""
Company
Dynarex Corporation
Model
10377
Device description
Weight Capacity 500 lbs.
Published
2022-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILSAdaptor, Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117324572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117324572008401173245728401173245720840117324572

GMDN Terms#

Term, Definition table
TermDefinition
Commode, manualA non-active, manually-operated transportable device in the form of a chair with a built-in receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., during shower). Also known as a sanichair, it may include hydraulically-assisted seat height adjustment, and may or may not be supplied with wheels (castors).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08
00616784418520Bandage Shears 7.5" (19.1 cm) Red41852020-11-08
00616784418629Bandage Shears 7.5" (19.1 cm) Teal41862020-11-08
00616784418728Bandage Shears 7.5" (19.1 cm) Yellow41872020-11-08
00616784419022Mini Scissors 4" (10.2 cm) Red41902020-11-08
00616784419121Bandage Shears 5.5" (14.0 cm) Black41912020-11-08
00616784419220Bandage Shears 5.5" (14.0 cm) Blue41922020-11-08
00616784419329Bandage Shears 5.5" (14.0 cm) Magenta41932020-11-08
00616784419428Bandage Shears, 5.5" (14.0 cm) Orange41942020-11-08
00616784419527Bandage Shears 5.5" (14.0 cm) Purple41952020-11-08
00616784419626Bandage Shears, 5.5" (14.0 cm) Red41962020-11-08
00616784419725Bandage Shears, 5.5" (14.0 cm) Teal41972020-11-08
00616784419824Bandage Shears,5.5" (14.0 cm) Yellow41982020-11-08
00616784711522PA SensiLance Pressure Activated Safety Lancets,Sterile71152021-05-21
00616784711621Disposable Ear Specula Tips, For Diagnostic Otoscopes, 2.5 mm, Pediatric71162021-05-21

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