FDA.report

SansaTM

Primary DI
G2331000000
Brand
SansaTM
Company
Huxley Medical, Inc.
Model
1000-00
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MNRVentilatory Effort Recorder

Product Code Classifications

CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions

SubmissionSupplement
K240285000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240285000Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical2024-07-15MNR

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G2331000000PrimaryHIBCC0

GMDN Terms

TermDefinition
Wearable multiple physiological parameter recorder, reusableAn electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117061985
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
G2331000010SansaTM1000-012024-10-21
G2331000020SansaTM1000-022024-10-21

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