FDA.reportPublic FDA data

Med-Mizer, Inc.

Primary DI
00852195007001
Brand
Med-Mizer, Inc.
Company
MED-MIZER, INC.
Model
EX8000
Device description
EX8000 Bariatric Bed
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852195007001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852195007001008521950070018521950070010852195007001

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric bedA mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
812-932-2345sales@med-mizer.com

Regulatory Flags#

DUNS number
136733990
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852195007506Med-Mizer, Inc.ComfortWide2026-04-17
00852195007469Med-Mizer, Inc.MedSurg2025-09-19
00852195007407Med-Mizer, Inc.ACGOV BASIC2025-03-22
00852195007414Med-Mizer, Inc.ACGOV ADVANCED2025-03-22
00852195007391Med-Mizer, Inc.ET4502025-03-06
00852195007384Med-Mizer, Inc.MED-RISER MR4502024-12-18
00852195007377Med-Mizer, Inc.FF18-MAG2024-03-13
00852195007155Med-Mizer, Inc.FLEXTILT 162023-06-13
00852195007162Med-Mizer, Inc.EX5000C2023-06-13
00852195007179Med-Mizer, Inc.FLEXTILT 242023-06-13
00852195007186Med-Mizer, Inc.FLEXTILT 202023-06-13
00852195007193Med-Mizer, Inc.ALLCARE2023-06-13
00852195007209Med-Mizer, Inc.FREEDOM FLEX 162023-06-13
00852195007216Med-Mizer, Inc.FREEDOM FLEX 202023-06-13
00852195007223Med-Mizer, Inc.FREEDOM FLEX 242023-06-13
00852195007230Med-Mizer, Inc.ALLCARE-C2023-06-13
00852195007247Med-Mizer, Inc.ACTIVECARE 36 ADJUST2023-06-13
00852195007254Med-Mizer, Inc.ACTIVECARE 42 ADJUST2023-06-13
00852195007261Med-Mizer, Inc.ACTIVECARE 42 FIXED2023-06-13
00852195007278Med-Mizer, Inc.ACTIVECARE 36 FIXED2023-06-13

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Primary DI, Brand, Company table
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