FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00653078997606
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
vkssc20.2
Catalog number
vkssc20.2
Device description
20 Pack Of 4oz Sterile Specimen Cups Individually Bagged With Screw On Lids
Published
2021-12-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653078997606PrimaryGS10
00850025452496Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653078997606006530789976066530789976060653078997606
00850025452496008500254524968500254524960850025452496

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
20
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
00879123009012BFlex™Verathon Medical (Canada) ULCFMH2026-05-29
H1084306551CorningCorning IncorporatedFMH2026-01-26
H1083540141Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540171Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540201Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117391CorningCorning IncorporatedFMH2026-01-14
H108117041CorningCorning IncorporatedFMH2025-10-28
10192253051490DoverCardinal Health 200, LLCFMH2025-09-30
10192253051513DoverCardinal Health 200, LLCFMH2025-09-30
10198459304637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
10198459382963MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
10080196035298MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
10198459351327MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
10198459319990Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-04-18
10193489013467MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-03-20
10198459295270Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-16
10198459277122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-02
10192253051636PrecisionCardinal Health 200, LLCFMH2025-02-19
10198459247897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10198459249303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10197344039517MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-01-31
10198459203176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-12-08
10198459190544Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-24
10198459179860Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
10198459181702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29
H1084316231CorningCorning IncorporatedFMH2024-10-29
H1084316241CorningCorning IncorporatedFMH2024-10-29