FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077212141
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
DCPx300
Catalog number
DCPx300
Device description
17''x24'' Underpads x300
Published
2021-10-15
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
EFWTOOTHBRUSH, MANUAL
KMEBEDDING, DISPOSABLE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810077211410PrimaryGS10
00810077211892PrimaryGS10
00810077212240PrimaryGS10
00810077212141Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077211410008100772114108100772114100810077211410
00810077211892008100772118928100772118920810077211892
00810077212240008100772122408100772122400810077212240
00810077212141008100772121418100772121410810077212141

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, non-antimicrobialA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
300
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
00810077210536Avaline Medical NJ LLCkueel5kueel52021-05-10
00810077210543Avaline Medical NJ LLCkuwml5kuwml52021-05-10
00850025452106Avaline Medical NJ LLCkuwml10kuwml102021-05-10
00850025452113Avaline Medical NJ LLCkuwmxl10kuwmxl102021-05-10
00810077211694Avaline Medical NJ LLCvk02muvk02mu2021-10-15
00810124537616VaklyVK346952026-07-16
00810124537647VaklyVK617402026-07-10
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

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00199972000573CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 228Dynarex CorporationKME2026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"Dynarex CorporationKME2026-07-31
00840456201435JMUJMU DENTAL, INCKME2026-07-06
00840456206362JMUJMU DENTAL, INCKME2026-07-06
00072239332559Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332566Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
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00072239334829Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334836Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
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
00072239328002Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239328149Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239330050Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332313Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332320Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332535Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332542Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239333129Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04