FDA.reportPublic FDA data

Medegen Medical Products, LLC

Primary DI
00700812001041
Brand
Medegen Medical Products, LLC
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
H113-07
Device description
Bedpan Commode Turq 50/cs 36/plt
Published
2020-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FOBBEDPAN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOBBedpanGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00700812001041PrimaryGS10
10700812001048Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00700812001041007008120010417008120010410700812001041
1070081200104810700812001048

GMDN Terms#

Term, Definition table
TermDefinition
BedpanA portable device used by a patient or a person with a disability that is confined to his/her bed as a receptacle in which to urinate and/or defecate. It will be removed and emptied by attending staff and sanitized for reuse. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055527753
Device count
50
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00700812003892Medegen Medical Products, LLC25652020-12-20
H3621580Medegen Medical products1581582016-09-23
H362158TY0Medegen Medical products158TY158TY2016-09-23
H362158V0Medegen Medical products158V158V2016-09-23
H3621780Medegen Medical products1781782016-09-23
H362178TY0Medegen Medical products178TY178TY2016-09-23
H362178V0Medegen Medical products178V178V2016-09-23
H3621800Medegen Medical products1801802016-09-23
H362180S0Medegen Medical products180S180S2016-09-23
H362180TY0Medegen Medical products180TY180TY2016-09-23
H362180V0Medegen Medical products180V180V2016-09-23
H3621820Medegen Medical products1821822016-09-23
H362182S0Medegen Medical products182S182S2016-09-23
H362182TY0Medegen Medical products182TY182TY2016-09-23
H362182V0Medegen Medical products182V182V2016-09-23
H3621840Medegen Medical products1841842016-09-23
H362184CN0Medegen Medical productsCN184CN1842016-09-23
H362184R0Medegen Medical products184R184R2016-09-23
H362184S0Medegen Medical products184S184S2016-09-23
H362184TY0Medegen Medical products184TY184TY2016-09-23

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Primary DI, Brand, Company table
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00194613096496MSI Precision Specialty InstrumentsMed Saver, Inc.FOB2025-08-01
00199284374782EnviroCare PouchEnviroCare Health Limited Liability CompanyFOB2025-06-30
00661392011953LSL HEALTHCARELSL Industries, LLCFOB2025-05-16
00661392012585LSL HEALTHCARELSL Industries, LLCFOB2025-05-16
10661392011950LSL HEALTHCARELSL Industries, LLCFOB2025-05-16
10661392012582LSL HEALTHCARELSL Industries, LLCFOB2025-05-16
00860010353271EnviroSorb® CommodeShield™LDI Solutions, LLCFOB2025-03-04
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00818323021752ViveVIVE HEALTH LLCFOB2024-01-12
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00810041989444ViveVIVE HEALTH LLCFOB2023-11-13
00810041989727ViveVIVE HEALTH LLCFOB2023-11-13
00810113574639ViveVIVE HEALTH LLCFOB2023-11-13
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00810113574660ViveVIVE HEALTH LLCFOB2023-11-13
00810113574783ViveVIVE HEALTH LLCFOB2023-11-13
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10810041989724ViveVIVE HEALTH LLCFOB2023-11-13
10810113574636ViveVIVE HEALTH LLCFOB2023-11-13