FDA.report

Medegen Medical Products, LLC

Primary DI
00700812012467
Brand
Medegen Medical Products, LLC
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
V4075
Device description
Bag: STB Zip 6x9 2ml Org/Blk 1000/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

Related Records

Product Codes

CodeName
NNICONTAINER, SPECIMEN, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00700812012467PrimaryGS10
10700812012464Unit of UseGS10

GMDN Terms

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

Regulatory Flags

DUNS number
055527753
Device count
1000
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 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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