FDA.reportPublic FDA data

Novera Breeze

Primary DI
00841277111125
Brand
Novera Breeze
Company
Harps USA, Inc.
Model
NVHMF0405 / NVFLM0447
Catalog number
NVHMF0405 / NVFLM0447
Device description
Novera Breeze transparent film dressing 4x4.75
Published
2026-10-30
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
00841277111125PrimaryGS10
00841277111118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277111125008412771111258412771111250841277111125
00841277111118008412771111188412771111180841277111118

Contacts#

Phone, Email table
PhoneEmail
800-366-9545Glove.Info@SempermedUSA.com

Regulatory Flags#

DUNS number
004072158
Device count
100
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
00841277110951Novera CloudNVSFB0404 / NVSFOB0404NVSFB0404 / NVSFOB04042026-10-30
00841277110975Novera CloudNVSFB0606 / NVSFOB0606NVSFB0606 / NVSFOB06062026-10-30
00841277111002Novera CloudNVSFO0404NVSFO04042026-10-30
00841277111026Novera CloudNVSFO0606NVSFO06062026-10-30
00841277111040Novera CloudNVSFS0707 / NVSFO0707NVSFS0707 / NVSFO07072026-10-30
00841277111064Novera CloudNVSFS0909 / NVSFO9292NVSFS0909 / NVSFO92922026-10-30
00841277111088Novera CloudNVSFB0303 / NVSFOB0303NVSFB0303 / NVSFOB03032026-10-30
00841277111101Novera BreezeNVHMF0203 / NVFLM2228NVHMF0203 / NVFLM22282026-10-30
00841277111149Novera BreezeNVHMR0203 / NVFLMR2228NVHMR0203 / NVFLMR22282026-10-30
00841277111163Novera BreezeNVHMR0405 / NVFLMR0447NVHMR0405 / NVFLMR04472026-10-30
00841277111309Novera SeamNVPOP0205 / NVPOP2405NVPOP0205 / NVPOP24052026-10-30
00841277111347Novera LockNVCHI0405 / NVCHD0448NVCHI0405 / NVCHD04482026-10-30
00841277111361Novera RenewNVAGA0606 / NVAGAL0606NVAGA0606 / NVAGAL06062026-10-30
00841277111385Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111187Novera RenewNVAGAL0202NVAGA0202 / NVAGAL02022026-08-26
00841277111392Novera SeamNVGOP0410NVAGP0410 / NVAGOP04102026-10-14
00841277111248Novera BalanceNVHYGE025GNVHGE0090 / NVHYGE025G2026-09-04
00841277111286Novera SeamNVPOP1004NVPOP0410 / NVPOP10042026-09-04
10841277111382Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111200Novera RenewNVAGAL0448NVAGA0405 / NVAGAL04482026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841277111101Novera BreezeHarps USA, Inc.NAD2026-10-30
00841277111149Novera BreezeHarps USA, Inc.NAD2026-10-30
00841277111163Novera BreezeHarps USA, Inc.NAD2026-10-30
06974795059366MEDLOTHenan Maidingkang Medical Technology Co., Ltd.NAD2026-10-29
10885632417122HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-10-21
10885632417146HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-10-21
M689HVPIK060H-Vent Vented Chest SealSafeguard US Operating, LLCNAD2026-10-13
00096295146639LEADERCardinal Health 110, Inc.NAD2026-10-09
08806109104180Madeca Medi Patch SpecialDongkook Pharmaceutical Co.,Ltd.NAD2026-09-30
08806109193573MADECA MEDI PATCH FREE-CUT PATCHDongkook Pharmaceutical Co.,Ltd.NAD2026-09-30
08806109193580MADECA MEDI PATCH FREE-CUT PATCHDongkook Pharmaceutical Co.,Ltd.NAD2026-09-30
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