FDA.reportPublic FDA data

NuVeria Labs

Primary DI
20850050711005
Brand
NuVeria Labs
Company
Remedium Healthcare Products LLC
Model
REMSF99B
Device description
NuVeria Labs bordered silicone foam dressing by Remedium Healthcare Products, 9x9
Published
2024-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850050711008PackageGS15In Commercial Distribution
20850050711005PackageGS125In Commercial Distribution
00850050711001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005071100810850050711008
2085005071100520850050711005
00850050711001008500507110018500507110010850050711001

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118955747
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00850050711391NuVeria LabsRHCFGA45RHCFGA452025-03-19
00850050711421NuVeria LabsRHCFGA66RHCFGA662025-03-19
00850050711445NuVeria LabsRHCFGA118RRHCFGA118R2025-03-19
00850050711476NuVeria LabsREMWBG22REMWBG222025-03-19
00850050711506NuVeria LabsREMWBG44REMWBG442025-03-19
00850050711537NuVeria LabsREMWBG66REMWBG662025-03-19
00850050711407NuVeria LabsRHCFGA45RHCFGA452025-03-19
10850050711428NuVeria LabsRHCFGA66RHCFGA662025-03-19
00850050711452NuVeria LabsRHCFGA118RRHCFGA118R2025-03-19
00850050711483NuVeria LabsREMWBG22REMWBG222025-03-19
00850050711513NuVeria LabsREMWBG44REMWBG442025-03-19
00850050711544NuVeria LabsREMWBG66REMWBG662025-03-19
00850050711360NuVeria LabsRHCFGA22RHCFGA222024-12-13
00850050711186NuVeria LabsREMFG222024-02-14
00850050711216NuVeria LabsREMFG452024-02-14
00850050711247NuVeria LabsREMFG662024-02-14
00850050711278NuVeria LabsREMFG118R2024-02-14
00850050711209NuVeria LabsREMFG222024-02-14
00850050711230NuVeria LabsREMFG452024-02-14
00850050711261NuVeria LabsREMFG662024-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756399258DeRoyalDEROYAL INDUSTRIES, INC.NAD2026-09-21
07333350341596Mepitel®Mölnlycke Health Care ABNAD2026-09-21
05701780265058Biatain AdhesiveColoplast A/SNAD2026-08-27
04719873697779NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697786NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697793NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697809NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697816NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697823NACARILEX MEDICAL, INC.NAD2026-08-26
00850088144925CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-08-14
040640351931573M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351931953M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351932323M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850087488686CeeportCEEPORT INC.NAD2026-06-30
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206823977kegel Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827067Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827074Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22