FDA.reportPublic FDA data

Medegen Medical Products, LLC

Primary DI
00700812000693
Brand
Medegen Medical Products, LLC
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
4090
Device description
Syringe Bulb 50/cs 48/plt
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
KYZSYRINGE, IRRIGATING (NON DENTAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00700812000693PrimaryGS10
10700812000690Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00700812000693007008120006937008120006930700812000693
1070081200069010700812000690

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055527753
Device count
50
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

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