Medegen Medical Products, LLC

Primary DI
00700812001263
Brand
Medegen Medical Products, LLC
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
H149-01
Device description
Urinal W/TransCvr Imp 50/cs 24/plt
Published
2020-12-20
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
FNPURINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNPUrinalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00700812001263PrimaryGS10
10700812001260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00700812001263007008120012637008120012630700812001263
1070081200126010700812001260

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held urinal, single-useA portable, hand-held container intended to be directly urinated into by a patient for excretory purposes; it may be specific to male or female patients, or unisex. It is typically in the form of a bottle with a handle, or a bag, or pouch; it may include a noninvasive funnel and tubing, and may have a drain with a stopper in it to facilitate emptying. It is not intended to be worn by the patient and is not intended to measure urine output. This is a single-use device.

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
00700812001201Medegen MedicalH140-01H140-012020-05-18
00700812001218Medegen Medical ProductsH140CR-01H140CR-012020-05-18
00700812001225Medegen Medical ProductsH140D-01H140D-012020-05-18
00700812001232Medegen Medical ProductsH141-01H141-012020-05-18
00700812003892Medegen Medical Products, LLC25652020-12-20
H3621580Medegen Medical products1581582016-09-23
H362158TY0Medegen Medical products158TY158TY2016-09-23
H362158V0Medegen Medical products158V158V2016-09-23
H3621780Medegen Medical products1781782016-09-23
H362178TY0Medegen Medical products178TY178TY2016-09-23
H362178V0Medegen Medical products178V178V2016-09-23
H3621800Medegen Medical products1801802016-09-23
H362180S0Medegen Medical products180S180S2016-09-23
H362180TY0Medegen Medical products180TY180TY2016-09-23
H362180V0Medegen Medical products180V180V2016-09-23
H3621820Medegen Medical products1821822016-09-23
H362182S0Medegen Medical products182S182S2016-09-23
H362182TY0Medegen Medical products182TY182TY2016-09-23
H362182V0Medegen Medical products182V182V2016-09-23
H3621840Medegen Medical products1841842016-09-23

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