FDA.reportPublic FDA data

Medegen Medical Products

Primary DI
10700812000461
Brand
Medegen Medical Products
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
02433
Catalog number
02433
Device description
Bowl 32oz White Non-Sterile 250/cs 24/plt
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNYBasin, Emesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00700812000464PrimaryGS10
10700812000461Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00700812000464007008120004647008120004640700812000464
1070081200046110700812000461

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose bowl, single-useA bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary from round, oblong, deep or quite shallow. This disposable device will typically be incinerated along with its contents if used for waste. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
901-867-4230dwyndl.nelms@medegenmed.com

Regulatory Flags#

DUNS number
055527753
Device count
250
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
true
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918130552AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2026-04-17
10198956251335CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251342CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251359CARDINAL HEALTHCardinal Health 200, LLCFNY2025-12-10
10198956138193CARDINAL HEALTHCardinal Health 200, LLCFNY2025-11-07
00661392001176LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012356LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012752LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392037977LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392053823LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392055063LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
10198956137714CARDINAL HEALTHCardinal Health 200, LLCFNY2025-08-28
16931918189192AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918190082AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918129310AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918140827AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918145464AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918146843Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918157085AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
00661392008083LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392025493LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392045330LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392027664LSL HEALTHCARELSL Industries, LLCFNY2025-05-15
00661392004627LSL HEALTHCARELSL Industries, LLCFNY2025-04-22
10198956044890CARDINAL HEALTHCardinal Health 200, LLCFNY2025-04-03
10197106833780CARDINAL HEALTHCardinal Health 200, LLCFNY2024-12-31
10840330701355ProCureTwin Med, LLCFNY2024-11-14
10840330701362ProCureTwin Med, LLCFNY2024-11-14
10840330701379ProCureTwin Med, LLCFNY2024-11-14
10840330701386ProCureTwin Med, LLCFNY2024-11-14