FDA.reportPublic FDA data

NuVeria Labs

Primary DI
00850050711506
Brand
NuVeria Labs
Company
Remedium Healthcare Products LLC
Model
REMWBG44
Catalog number
REMWBG44
Device description
"NuVeria Labs water-resistant bordered gauze dressing by Remedium Healthcare Products, 4""x4"""
Published
2025-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850050711513PackageGS110In Commercial Distribution
00850050711520PackageGS1200In Commercial Distribution
00850050711506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050711513008500507115138500507115130850050711513
00850050711520008500507115208500507115200850050711520
00850050711506008500507115068500507115060850050711506

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.

Regulatory Flags#

DUNS number
118955747
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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
00850050711292NuVeria LabsREMFG118R2024-02-14

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Primary DI, Brand, Company table
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