FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077219898
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
VKAEP480
Device description
Adhesive Eye Patch
Published
2023-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMPPAD, EYE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMPPad, EyeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810077219904PrimaryGS10
00810077219911PrimaryGS10
00810077219928PrimaryGS10
00810077219935PrimaryGS10
00810077219942PrimaryGS10
00810077219959PrimaryGS10
00810077219898Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077219904008100772199048100772199040810077219904
00810077219911008100772199118100772199110810077219911
00810077219928008100772199288100772199280810077219928
00810077219935008100772199358100772199350810077219935
00810077219942008100772199428100772199420810077219942
00810077219959008100772199598100772199590810077219959
00810077219898008100772198988100772198980810077219898

GMDN Terms#

Term, Definition table
TermDefinition
Eye patchA device intended to be used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention. It is made of a synthetic or biological material. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
480
DM exempt
false
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
true
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
06950396345510Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-02-26
06950396345527Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-02-26
06950396345435Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-01-28
06950396345459Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-01-28
00810124532116Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532123Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532130Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532147Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532109Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
10653160388708MEDLINEMEDLINE INDUSTRIES, INC.HMP2025-07-14
00653160388701MEDLINEMEDLINE INDUSTRIES, INC.HMP2025-07-14
08681756010349PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756010356PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756010028PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756012916PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08682952413262PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
00690521023932Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
00690521023949Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
00690521025165Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
16974567748075RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
16974567748082RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
06974567748085RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
06974567748078RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
00840117334762"Eyepad - 18""x 36"" "Dynarex CorporationHMP2024-03-25
00840117334755Eyepad - 18"x 36" DYNAREX CORPORATIONHMP2024-03-25
00810077219904Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219911Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219928Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219935Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219942Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04