FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077213209
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
vk5cbp
Catalog number
vk5cbp
Device description
Stackable Contour Bedpansx5
Published
2022-03-05
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

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
00810077213117PrimaryGS10
00810077213209Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077213117008100772131178100772131170810077213117
00810077213209008100772132098100772132090810077213209

GMDN Terms#

Term, Definition table
TermDefinition
BedpanA portable device used by a patient or a person with a disability that is confined to his/her bed as a receptacle in which to urinate and/or defecate. It will be removed and emptied by attending staff and sanitized for reuse. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

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