FDA.reportPublic FDA data

Medegen Medical Products, LLC

Primary DI
00673844003188
Brand
Medegen Medical Products, LLC
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
AC323
Device description
Bag: Ac 38X46 2.0Ml Clr Ind 100/Cs
Published
2020-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NNICONTAINER, SPECIMEN, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673844003188PrimaryGS10
10673844003185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673844003188006738440031886738440031880673844003188
1067384400318510673844003185

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive, non-sterileA covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055527753
Device count
100
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
00810180842211LabChoice Sputum Containers, 40 mL Dynarex CorporationNNI2025-06-16
00840117337367LabChoice Pet Cell Bottle, 250 mL Dynarex CorporationNNI2025-06-16
00840117337374LabChoice Pet Cell Bottle, 500 mL Dynarex CorporationNNI2025-06-16
00840117337381LabChoice Pet Cell Bottle, 1000 mL Dynarex CorporationNNI2025-06-16
00840165500218HistoplexStarplex Scientific Corp.NNI2025-05-30
00840165500096StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
00840165500119LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500133LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500157LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500171LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500195HistoplexStarplex Scientific Corp.NNI2025-05-28
00840165500416LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500430LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165401195LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840165401416LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840117336414LabChoice 24-Hour Urine Collection Container, 3000 mL Dynarex CorporationNNI2025-04-17
10827989003214Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-04-15
00810180841689LabChoice Specimen Bags, Clear, 8" x 10", 1.8 MILDynarex CorporationNNI2025-04-07
00810180841672LabChoice Specimen Bags with Pouch, 4" x 6", 1.8 MIL Dynarex CorporationNNI2025-04-07
29120126131459VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00810180841665LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-SterileDynarex CorporationNNI2025-03-28
00810180841658LabChoice Specimen Bags, 12" x 15", 1.8 milDynarex CorporationNNI2025-03-28
10827989003221Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-03-13
00810180841467LabChoice Specimen Containers, 60 mL, Non-SterileDynarex CorporationNNI2025-03-11
00810180841474LabChoice Specimen Containers, 100 mL, NonSterileDynarex CorporationNNI2025-03-11
00810180841450LabChoice Specimen Containers, 40 mL, Non-SterileDynarex CorporationNNI2025-03-11
00860009784895Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
00840165400976Starplex Pretium Canada Packaging ULCNNI2025-03-04
00850025860017ESD Specimen TrayMicro-tech UsaNNI2025-02-28
04250306301219SalivaGene CollectorInvitek Molecular GmbHNNI2025-02-12