FDA.reportPublic FDA data

Medegen Medical Products

Primary DI
10700812007897
Brand
Medegen Medical Products
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
PO1630-250
Catalog number
PO1630-250
Device description
Bowl 32oz Blue RS Non-Sterile 250/cs
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
00700812007890PrimaryGS10
10700812007897Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00700812007890007008120078907008120078900700812007890
1070081200789710700812007897

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
H3621872Medegen Medical products1871872016-09-23
00673844000231Medegen Medical Products, LLC1005A2020-09-20
00673844000248Medegen Medical Products, LLC1015A2020-09-20
00673844000255Medegen Medical Products, LLC104M2020-09-20
00673844000262Medegen Medical Products, LLC108M2020-09-20
00673844000279Medegen Medical Products, LLC108MBX2020-09-20
00673844000286Medegen Medical Products, LLC108MP2020-09-20
00673844000293Medegen Medical Products, LLC1092020-09-20
00673844000316Medegen Medical Products, LLC115H2020-09-20
00673844000323Medegen Medical Products, LLC1162020-09-20
00673844000330Medegen Medical Products, LLC116BX2020-09-20
00673844000347Medegen Medical Products, LLC1172020-09-20
00673844000354Medegen Medical Products, LLC117A2020-09-20
00673844000361Medegen Medical Products, LLC117M2020-09-20
00673844000378Medegen Medical Products, LLC117MBX2020-09-20
00673844000385Medegen Medical Products, LLC117MP2020-09-20
00673844000392Medegen Medical Products, LLC1192020-09-20
00673844000408Medegen Medical Products, LLC148282442020-09-20
00673844000415Medegen Medical Products, LLC148282452020-09-20
00673844000422Medegen Medical Products, LLC148282462020-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956251357CARDINAL HEALTHCardinal Health 200, LLCFNY2025-12-10
00840216128262ASP GLOBALAsp Global, LLCFNY2025-11-20
00840216128286ASP GLOBALAsp Global, LLCFNY2025-11-20
50198956137712CARDINAL HEALTHCardinal Health 200, LLCFNY2025-08-28
00194613019600MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
00194613019914MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
00194613052256MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
00194613116972MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
06931918189195AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
06931918190085AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
06931918129313AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
06931918140820AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
06931918145467AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
26931918146840Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
06931918157088AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
00840216128279ASP GLOBALAsp Global, LLCFNY2025-06-17
00840216128293ASP GLOBALAsp Global, LLCFNY2025-06-17
00810180842228DispoSafety Biohazard Bags, 39" x 33", 2 MIL, 33 GallonDynarex CorporationFNY2025-06-16
00810180842235DispoSafety Biohazard Bags, 40" x 46", 2 MIL, 45 GallonDynarex CorporationFNY2025-06-16
00810180842242DispoSafety Biohazard Bags, 40" x 46", 3 MIL, 45 GallonDynarex CorporationFNY2025-06-16
00810180842259DispoSafety Biohazard Bags, 36" x 58", 2 MIL, 45 GallonDynarex CorporationFNY2025-06-16
10661392008080LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
10661392025490LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
10661392045337LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
10661392027661LSL HEALTHCARELSL Industries, LLCFNY2025-05-15
10661392004624LSL HEALTHCARELSL Industries, LLCFNY2025-04-22
00810180841702DispoSafety Medical Waste Biohazard Bags, 24" x 25.6", 1.18 MIL, 12 GallonDynarex CorporationFNY2025-04-07
00810180841719DispoSafety Medical Waste Biohazard Bags, 36" x 30", 1.2 MIL, 30 GallonDynarex CorporationFNY2025-04-07
00810180841696DispoSafety Medical Waste, Biohazard Bags with Ties,12 Gal,24" x 25.6",0.78 MIL Dynarex CorporationFNY2025-04-07
50198956044898CARDINAL HEALTHCardinal Health 200, LLCFNY2025-04-03