FDA.reportPublic FDA data

NOVAPLUS Sterile Water for Inhalation

Primary DI
00810083350325
Brand
NOVAPLUS Sterile Water for Inhalation
Company
Sensimedical LLC
Model
V7871800000
Catalog number
V7871800000
Device description
Sterile Water for Inhalation, USP, 1000 mL
Published
2022-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881184000INTERTECH STERILE WATER FOR INHALATIONDelmed, Inc.1988-05-25BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810083350325PackageGS114In Commercial Distribution
00810083350332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810083350325008100833503258100833503250810083350325
00810083350332008100833503328100833503320810083350332

GMDN Terms#

Term, Definition table
TermDefinition
Non-heated respiratory humidifierA device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (reservoir) for the water, a top piece that functions as a detachable lid (typically a screw lid with a gastight seal), and a tube that protrudes into the water to divert the gas below the water level. This device, commonly known as a bubble humidifier, does not heat the water. It has connectors: 1) one (e.g., a winged nut) that connects to an oxygen therapy flowmeter; and 2) one to which the patient tubing is connected. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117526048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810083351100SENSIMEDICAL Sterile Water, USP787180006178718000612025-10-06
00810083350462BIOSITE/BIOSITE PLUSJR-017-AUJR-017-AU2024-05-28
00810083350523BIOSITE/BIOSITE PLUSJR-044-AUJR-044-AU2024-05-28

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