FDA.reportPublic FDA data

SENSIMEDICAL Sterile 0.9% Normal Saline, USP

Primary DI
00810083351223
Brand
SENSIMEDICAL Sterile 0.9% Normal Saline, USP
Company
Sensimedical LLC
Model
7871800067
Catalog number
7871800067
Device description
Sterile 0.9% Normal Saline for Irrigation, USP, 500mL Bottle (OTC)
Published
2025-10-09
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
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810083351216PackageGS118In Commercial Distribution
00810083351223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810083351216008100833512168100833512160810083351216
00810083351223008100833512238100833512230810083351223

GMDN Terms#

Term, Definition table
TermDefinition
Non-antimicrobial wound irrigation solution, salineA solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and may be supplied in a plastic container with a spray nozzle; it is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
117526048
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810083350271SENSIMEDICAL Sterile Water for Inhalation, USP787180000078718000002022-06-23
00810083350332NOVAPLUS Sterile Water for InhalationV7871800000V78718000002022-06-23
00810083350356NOVAPLUS Sterile Water for Inhalation, USPV7871800002V78718000022022-06-23
00810083350561SENSIMEDICAL Sterile Water for Inhalation, USP787180004578718000452025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USP787180004678718000462025-10-06
00810083350295SENSIMEDICAL Sterile Water for Inhalation, USP787180000278718000022022-06-23
00810083350608SENSIMEDICAL Sterile Water, USP787180004778718000472025-10-09
00810083350622SENSIMEDICAL Sterile Water, USP787180004878718000482025-10-09
00810083350646SENSIMEDICAL Sterile Water, USP787180004978718000492025-10-09
00810083350660SENSIMEDICAL Sterile Water, USP787180005078718000502025-10-09
00810083350707SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180005278718000522025-10-09
00810083350721SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180005378718000532025-10-09
00810083350745SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180005478718000542025-10-09
00810083350769SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180005578718000552025-10-09
00810083351124SENSIMEDICAL Sterile Water, USP787180006278718000622025-10-09
00810083351148SENSIMEDICAL Sterile Water, USP787180006378718000632025-10-09
00810083351186SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180006578718000652025-10-09
00810083351209SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180006678718000662025-10-09
00810083351247SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180006878718000682025-10-09
00810083351087SENSIMEDICAL Sterile Water, USP787180006078718000602025-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
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05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011188Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08