FDA.reportPublic FDA data

Medegen Medical Products, LLC

Primary DI
00700812002499
Brand
Medegen Medical Products, LLC
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
02090
Device description
Bottle 24Hr Coll. 3000ml Amber 40/cs 16/
Published
2020-12-20
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

Product Codes#

Code, Name table
CodeName
KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00700812002499PrimaryGS10
10700812002496Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00700812002499007008120024997008120024990700812002499
1070081200249610700812002496

GMDN Terms#

Term, Definition table
TermDefinition
24-hour urine specimen container IVD, no additiveA capped plastic receptacle, typically 2 to 4 litres, with no additives and intended to be used for the collection, and preservation and/or transport, of urine collected over a 24-hour period for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055527753
Device count
40
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
04816415501263FOOT URINE COLLECTORASSOMEDIKA, OOOKNX2026-05-26
04816415501270BEDSIDE URINE COLLECTORASSOMEDIKA, OOOKNX2026-05-26
50192253068601DoverCardinal Health 200, LLCKNX2026-01-16
50192253068717DoverCardinal Health 200, LLCKNX2026-01-16
50192253068724DoverCardinal Health 200, LLCKNX2026-01-16
50192253068731DoverCardinal Health 200, LLCKNX2026-01-16
50192253067987DoverCardinal Health 200, LLCKNX2026-01-15
50192253068014DoverCardinal Health 200, LLCKNX2026-01-15
50192253068212DoverCardinal Health 200, LLCKNX2026-01-15
16974500612586Disposable Urinary Drainage BagGCMEDICA ENTERPRISE LTD.(WUXI)KNX2025-08-07
30840330701793ProCureTwin Med, LLCKNX2025-05-31
30840330701809ProCureTwin Med, LLCKNX2025-05-31
50192253027790DoverCardinal Health 200, LLCKNX2025-04-01
50192253028230DoverCardinal Health 200, LLCKNX2025-04-01
50192253032169DoverCardinal Health 200, LLCKNX2025-04-01
50192253030059DoverCardinal Health 200, LLCKNX2025-04-01
50192253027943DoverCardinal Health 200, LLCKNX2025-03-20
50850045818390TruCathHR PHARMACEUTICALS INC.KNX2025-02-17
50850045818406TruCathHR PHARMACEUTICALS INC.KNX2025-02-17
50192253028568DoverCardinal Health 200, LLCKNX2024-12-20
50192253028520DoverCardinal Health 200, LLCKNX2024-12-20
50192253028537DoverCardinal Health 200, LLCKNX2024-12-20
50192253028544DoverCardinal Health 200, LLCKNX2024-12-20
50192253028469DoverCardinal Health 200, LLCKNX2024-12-20
50192253031124DoverCardinal Health 200, LLCKNX2024-12-20
50192253028551DoverCardinal Health 200, LLCKNX2024-12-20
50192253027936DoverCardinal Health 200, LLCKNX2024-11-04
50192253028285DoverCardinal Health 200, LLCKNX2024-11-04
50192253028490DoverCardinal Health 200, LLCKNX2024-11-04
50192253031445DoverCardinal Health 200, LLCKNX2024-11-04