FDA.reportPublic FDA data

NuVeria Labs

Primary DI
00850050711209
Brand
NuVeria Labs
Company
Remedium Healthcare Products LLC
Model
REMFG22
Device description
NuVeria Labs gelling fiber dressing by Remedium Healthcare Products, 2"x2"
Published
2024-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050711193PackageGS110In Commercial Distribution
00850050711209PackageGS1100In Commercial Distribution
00850050711186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050711193008500507111938500507111930850050711193
00850050711209008500507112098500507112090850050711209
00850050711186008500507111868500507111860850050711186

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
true
Manufacturing date on label
true
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
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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