FDA.reportPublic FDA data

Nurochek-Pro Saline Solution

Primary DI
09357225006029
Brand
Nurochek-Pro Saline Solution
Company
HEADSAFE MFG PTY LTD
Model
Saline Solution Bottle Assembly (HS03-368)
Catalog number
HS03-368
Device description
The Nurochek-Pro Saline Solution is a non-sterile accessory intended for use with the Nurochek-Pro medical device system. The solution is used to support electrical contact between the Nurochek-Pro headset sensors and the skin during device operation. The saline solution has no independent diagnostic or therapeutic function and is not intended to be used on a standalone basis. The product is supplied for use by healthcare professionals in accordance with the Nurochek-Pro system Instructions for Use.
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMCReduced- Montage Standard Electroencephalograph
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- Montage Standard ElectroencephalographNeurology2
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243426000Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.2025-03-27PIW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09357225006029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09357225006029093572250060299357225006029

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61413133492support@team.headsafe.com

Regulatory Flags#

DUNS number
748905226
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09357225002014Nurochek-Pro Headset Nurochek-Pro Headset Assembly (HS03-267)HS03-2672026-03-18
09357225001017Nurochek-Pro Headset Nurochek-Pro Headset Assembly (HS03-267)HS03-2672025-12-15
09357225000041Nurochek-ProNurochek-Pro Kit (HS03-369) rev 2HS03-3692026-01-23
09357225000034Nurochek-ProNurochek-Pro Kit (HS03-369) rev 1HS03-3692025-12-15
09357225002021Nurochek-Pro Application Nurochek-Pro Application (HS03-303)2025-12-15
09357225002038Nurochek-Pro ServerNurochek-Pro Server (HS03-304)HS03-3042025-12-15
09357225003028Nurochek-Pro Soft Sensor KitNurochek-Pro Soft Sensor Kit (HS03-313)HS03-3132025-12-15

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