FDA.reportPublic FDA data

SENSIMEDICAL Sterile Water, USP

Primary DI
00810083351100
Brand
SENSIMEDICAL Sterile Water, USP
Company
Sensimedical LLC
Model
7871800061
Catalog number
7871800061
Device description
Sterile Water for Irrigation, USP, 250mL Bottle (OTC)
Published
2025-10-06
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
00810083351094PackageGS124In Commercial Distribution
00810083351100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810083351094008100833510948100833510940810083351094
00810083351100008100833511008100833511000810083351100

GMDN Terms#

Term, Definition table
TermDefinition
Wound irrigation sterile waterA fluid consisting of sterile water (no other compounds/additives) 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 typically provided in an appropriate container. 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
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
00810083351223SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180006778718000672025-10-09
00810083351247SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180006878718000682025-10-09
00810083350561SENSIMEDICAL Sterile Water for Inhalation, USP787180004578718000452025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USP787180004678718000462025-10-06
00810083351087SENSIMEDICAL Sterile Water, USP787180006078718000602025-10-06
00810083350462BIOSITE/BIOSITE PLUSJR-017-AUJR-017-AU2024-05-28
00810083350523BIOSITE/BIOSITE PLUSJR-044-AUJR-044-AU2024-05-28
00810083350905BIOSITE/BIOSITE PLUSJR-015-AUJR-015-AU2024-05-28

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