FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077211694
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
vk02mu
Catalog number
vk02mu
Device description
Male Urinal With Cover x2
Published
2021-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00810077211694PrimaryGS10
00810077211687Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077211694008100772116948100772116940810077211694
00810077211687008100772116878100772116870810077211687

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held urinal, reusableA 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. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(732)813-7799jstein@avalinemedical.com

Regulatory Flags#

DUNS number
079767953
Device count
2
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810077219904Avaline Medical NJ LLCVKAEP202023-11-04
00810077219911Avaline Medical NJ LLCVKAEP402023-11-04
00810077219928Avaline Medical NJ LLCVKAEP602023-11-04
00810077219935Avaline Medical NJ LLCVKAEP1202023-11-04
00810077219942Avaline Medical NJ LLCVKAEP2402023-11-04
00810077219959Avaline Medical NJ LLCVKAEP4802023-11-04
00810124536794Avaline Medical NJ LLCVK97245VK972452025-12-05
00810124536831Avaline Medical NJ LLCVK97223VK972232025-12-05
00810124536855Avaline Medical NJ LLCVK15236VK152362025-12-05
00810124536886Avaline Medical NJ LLCVK15296VK152962025-12-05
00810124536787Avaline Medical NJ LLCVK97245VK972452025-12-05
00810124536824Avaline Medical NJ LLCVK97223VK972232025-12-05
00810124536848Avaline Medical NJ LLCVK15236VK152362025-12-05
00810124536879Avaline Medical NJ LLCVK15296VK152962025-12-05
00810124536909Avaline Medical NJ LLCVK69576VK695762025-12-05
00810124536923Avaline Medical NJ LLCVK45915VK459152025-12-05
00810124531843Avaline Medical NJ LLC1lb C-Rollx32025-09-03
00810124532116Avaline Medical NJ LLCOEP x252025-09-03
00810124532123Avaline Medical NJ LLCOEP x502025-09-03
00810124532130Avaline Medical NJ LLCOEP x1002025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20748426261745Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261758Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261765Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261772Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261789Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261796Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261802Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261819Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261826Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261833Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261840Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261857Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261864Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261871Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261888Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261895Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261752Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261769Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261776Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261783Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261790Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261806Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261813Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261820Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261837Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261844Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261851Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261868Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261875Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261882Medline-MicrotekMicrotek Medical LLCFNP2026-01-28