medegenmed.comMAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
MEDEGEN MEDICAL MANUFACTURING SERVICES
Medegen Medical Products
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1043646 | 1043646 | Medegen Medical Products | 1 | Y | 2026-01-01 | 209 MEDEGEN DR. GALLAWAY TN US 38036 |
| 1123871 | 3003906761 | Medegen Medical Products | 1 | N | 2020-04-25 | 10 Columbia Blvd CLARKSBURG WV US 26301 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00700812001201 | Medegen Medical - Urinal wTransCvr 50/cs 24/plt | 901-867-4230 | dwyndl.nelms@medegenmed.com |
| 00700812001218 | Medegen Medical Products - Urinal w/Comfort Ring Att 50/cs 24/plt | 901-867-4230 | dwyndl.nelms@medegenmed.com |
| 00700812001225 | Medegen Medical Products - Urinal wTransCvr Delux 50/cs 24/plt | 901-867-4230 | dwyndl.nelms@medegenmed.com |
| 00700812001232 | Medegen Medical Products - Urinal wTransCvr Bagged 50/cs 18/plt | 901-867-4230 | dwyndl.nelms@medegenmed.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 13545 | 2070735805 | K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | LIO | 1996-04-03 |
| 13545 | 1007523286 | K943499 | KULTSURE STARSWAB(M240), MODIFICATION | JSM | 1994-11-30 |
| 172141 | 1588051666 | K942054 | SHARPS-TAINER | FMI | 1994-08-23 |
| 13545 | 1588051666 | K942054 | SHARPS-TAINER | FMI | 1994-08-23 |
| 13545 | 1243440510 | K850199 | POLY-LINED TOWEL/DRAPE LINE | KKX | 1985-02-21 |
| 13545 | 1044935314 | K032246 | MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | JSM | 2003-08-13 |
| 172141 | 1758286949 | ||||
| 13545 | 1058592641 | ||||
| 13545 | 1087178850 | ||||
| 13545 | 1207845507 | ||||
| 13545 | 1220044034 | ||||
| 13545 | 1263816179 | ||||
| 13545 | 1283991470 | ||||
| 13545 | 1309212097 | ||||
| 13545 | 1337472063 | ||||
| 13545 | 1410093910 | ||||
| 13545 | 1418582580 | ||||
| 13545 | 1444111306 | ||||
| 13545 | 1463754171 | ||||
| 13545 | 1472670519 | ||||
| 13545 | 1493500029 | ||||
| 13545 | 1512415531 | ||||
| 13545 | 1516264800 | ||||
| 13545 | 1600012813 | ||||
| 13545 | 1680977997 | ||||
| 13545 | 1696353644 | ||||
| 13545 | 1696626920 | ||||
| 13545 | 1712430453 | ||||
| 13545 | 1758286949 | ||||
| 13545 | 1764710560 | ||||
| 13545 | 1864311363 | ||||
| 13545 | 1887658064 | ||||
| 13545 | 1920211148 | ||||
| 13545 | 1932518471 | ||||
| 13545 | 1972282346 | ||||
| 13545 | 1999942226 | ||||
| 13545 | 2015158337 | ||||
| 13545 | 2065345103 | ||||
| 13545 | 2066533690 |
Product Codes Associated With Registrations#
PMN#
MEDEGEN PRESSURE RATED EXTENSION SETS
MEDEGEN INC.
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
MEDEGEN MEDICAL MANUFACTURING SYSTEM
TRU-SWAB STOCOCK
MEDEGEN MEDICAL MANUFACTURING SERVICES
DRUG ACCESS SPIKE
MEDEGEN MEDICAL MANUFACTURING SERVICES
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
MEDEGEN MEDICAL MANUFACTURING SYSTEM
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
MEDEGEN MEDICAL MANUFACTURING SERVICES
MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
MEDEGEN MEDICAL MANUFACTURING SERVICES, INC.
GUDID#
Medegen Medical Products, LLC - Urinal W/TransCvr Imp 50/cs 24/plt
2020-12-20
Medegen Medical Products - Urinal wTransCvr Bagged 50/cs 18/plt
2020-05-18
Medegen Medical Products - Urinal wTransCvr Delux 50/cs 24/plt
2020-05-18
Medegen Medical Products - Urinal w/Comfort Ring Att 50/cs 24/plt
2020-05-18
Medegen Medical - Urinal wTransCvr 50/cs 24/plt
2020-05-18
Medegen Medical Products, LLC - Set Vaginal Irrigation 50/c3s 60/plt
2020-12-20
Medegen Medical Products, LLC - 8708TYF
2018-07-27
Medegen Medical Products - Sharps: .7Qt Btl Red
2019-06-14
Medegen Medical products - STACKABLE CONTAINER 1 GALLON TRANSLUCENT RED W/DOME LID
2016-09-23
Medegen Medical products - STACKABLE CONTAINER 1 QT. TRANSLUCENT RED W/LID
2016-09-23
Medegen Medical Products, LLC - Sharps: 10Qt Btl Clr Sl/Sc 12/Cs
2019-02-17
Medegen Medical Products, LLC - Sharps: 23Qt Btl Clr Sl/Sc 4/Cs
2019-02-17
Medegen Medical Products, LLC - Sharps: Oval 12Qt Btl Clr Sl/Sc 12/Cs
2019-02-17
Medegen Medical Products, LLC - SHARPS: SCR CP 6.2 QT
2019-02-17
Medegen Medical Products, LLC - Sharps: 4.7Qt Btl Clr Sl/Sc 12/Cs
2019-02-17
Medegen Medical Products, LLC - Sharps: 1.7Qt Btl Clr 20/Cs
2019-02-17
Medegen Medical Products, LLC - Sharps: .7Qt Btl Clr 40/Cs
2019-02-17
Medegen Medical products - STACKABLE CONTAINER 1 QUART W/LID
2016-09-23
Medegen Medical products - STACKABLE CONTAINER 1 QT RED W /WLID
2016-09-23
Medegen Medical Products, LLC - Kit Spill Clean Up 16/cs
2020-12-20
Medegen Medical Products, LLC - Kit: Bio-Haz Econo 72/cs 15/plt
2020-12-20
Medegen Medical Products, LLC - Kit: Bio-Haz Deluxe Emerg Respo 6/cs
2020-12-20
Medegen Medical Products, LLC - Kit: BioHaz Red-Z Emer Respo (Box) 36/cs
2020-12-20
Medegen Medical products - Sharps: 23 Qt. Btl Red
2016-09-23
Medegen Medical Products - SHARPS CONTAINER 1 QUART W/LID - Label in English and French
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 3 GALLON TL RED W/LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 3 GALLON CLEAR WITH LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 5.4 QT. TRANSLUCENT YELLOW W/LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 5.4 QT. TRANSLUCENT RED W/LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 5.4 QT. CLEAR W / LID
2020-05-18
Medegen Medical Products - Sharp: Stack 2 Gal Dome lid Yel 10/cs24p
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 2 GALLON TRANSLUCENT YELLOW W/DOME LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 2 GALLON TRANSLUCENT RED W/DOME LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 1 GALLON TRANSLUCENT RED W/DOME LID
2020-05-18
Medegen Medical Products - SHARPS CONTAINER 8 GALLON TRANSLUCENT YELLOW W/LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 8 GALLON TRANSLUCENT YELLOW W/LID
2020-05-18
Medegen Medical Prodcuts - STACKABLE CONTAINER 8 GALLON TRANSLUCENT RED W/LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 8 GALLON W/LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 2 GALLON RED W/LID
2020-05-18
Medegen Medical Products - STACKABLE CONTAINER 2 GALLON TRANSLUCENT YELLOW W/FLAT LID
2020-05-18