FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077210796
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
DS40X48X50
Catalog number
DS40X48X50
Device description
"Vakly 2-Ply Drape Sheet - 40""x 48"", White (50 Pack)"
Published
2021-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBEDDING, DISPOSABLE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810077210796PrimaryGS10
00810077210802Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077210796008100772107968100772107960810077210796
00810077210802008100772108028100772108020810077210802

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
50
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
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
00199536911109BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
16931918129815HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
10889483602911AirLife™AirLife Finland OyKME2025-04-17
10889483602928AirLife™AirLife Finland OyKME2025-04-17
10889483602935AirLife™AirLife Finland OyKME2025-04-17
10889483602942AirLife™AirLife Finland OyKME2025-04-17
10889483603031AirLife™AirLife Finland OyKME2025-04-17
10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08