FDA.reportPublic FDA data

AcuPebble

Primary DI
05060759090238
Brand
AcuPebble
Company
ACURABLE LIMITED
Model
Ox100
Published
2024-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222950000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222950000AcuPebble OX100Acurable Limited2023-02-03MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060759090238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060759090238050607590902385060759090238

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
221978396
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDMNR2026-03-12
00840067104224CadwellCADWELL INDUSTRIES, INC.MNR2026-03-02
00840067104217CadwellCADWELL INDUSTRIES, INC.MNR2026-03-01
00840067104132Cadwell BlueBirdCADWELL INDUSTRIES, INC.MNR2025-12-31
00840067104156Cadwell BlueBirdCADWELL INDUSTRIES, INC.MNR2025-12-31
00840067104170Cadwell BlueBirdCADWELL INDUSTRIES, INC.MNR2025-12-31
07290109223575WatchPAT400ITAMAR MEDICAL LTDMNR2025-12-01
13700546709934Withings®WITHINGSMNR2025-11-30
03700546710209Withings®WITHINGSMNR2025-11-30
09353645351022NIGHTOWL RESMED ASIA PTE. LTD.MNR2025-08-04
00850063034272Night ShiftADVANCED BRAIN MONITORING, INC.MNR2025-07-21
00850063034289Night ShiftADVANCED BRAIN MONITORING, INC.MNR2025-07-21
00860007837036CASSIETatch Inc.MNR2025-05-09
B140MDO0BRAEBON MediOXBraebon Medical CorporationMNR2025-04-28
B140MDOK0BRAEBON MediByte Jr. KitBraebon Medical CorporationMNR2025-04-28
00864458000469EnsoSleep PPGENSODATA, INC.MNR2025-04-14
00864458000452Celeste+ENSODATA, INC.MNR2025-04-07
00382830023955NatusXLTEKMNR2025-02-27
00382830023986NatusXLTEKMNR2025-02-27
00382830026765NatusXLTEKMNR2025-02-27
00382830027236NatusXLTEKMNR2025-02-27
00382830027243NatusXLTEKMNR2025-02-27
00382830027250NatusXLTEKMNR2025-02-27
00382830059244NatusXLTEKMNR2025-02-27