FDA.reportPublic FDA data

Sleepiz One+

Primary DI
07649996477019
Brand
Sleepiz One+
Company
Sleepiz AG
Model
1.0
Published
2024-05-14
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
false

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223163000Sleepiz One+Sleepiz AG2023-08-18DRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649996477019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649996477019076499964770197649996477019

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, home-useAn assembly of electrically-powered devices designed to be used by a layperson in the home for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480221620
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
true
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20653405024948CONMEDConmed CorporationBZQ2026-03-24
20653405048142CONMEDConmed CorporationBZQ2026-03-24
20889483224363MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
20889483225292MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
B1400580A1BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for AliceBraebon Medical CorporationBZQ2026-03-06
B1400580D1BRAEBON PT2 Dual Differntial Airflow Pressure KitBraebon Medical CorporationBZQ2026-03-06
B1400580N1BRAEBON Ultima Airflow Pressure KitBraebon Medical CorporationBZQ2026-03-06
B1400580PES1BRAEBON Ultima Esophageal Pressure TransducerBraebon Medical CorporationBZQ2026-03-06
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.BZQ2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyBZQ2025-12-10
08809988780049Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)Xandar Kardian Korea Inc.BZQ2025-12-04
06944413838437Patient MonitorEdan Instruments, Inc.BZQ2025-09-05
06944413838444Patient MonitorEdan Instruments, Inc.BZQ2025-09-05
30889483610569Resmed Sleep Apnealink CannulaSALTER LABSBZQ2025-07-11
B14003760BRAEBON Interface Cable for Alice 6Braebon Medical CorporationBZQ2025-04-30
B1400580AXA0BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for AliceBraebon Medical CorporationBZQ2025-04-30
00860004541745ANNE ChestSibel Health Inc.BZQ2025-04-02
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.BZQ2025-03-13
00843997006187Radius VSMMASIMO CORPORATIONBZQ2024-08-19
06944413815902Patient MonitorEdan Instruments, Inc.BZQ2024-06-17
B1400514A0BRAEBON cTherm Cannula Thermistor for Alice PDXBraebon Medical CorporationBZQ2024-03-25
B1400572A0BRAEBON Q-RIP Belt for AliceBraebon Medical CorporationBZQ2024-03-25
B1400572AL0BRAEBON Q-RIP Belt for Alice, LargeBraebon Medical CorporationBZQ2024-03-25
B1400572APED0BRAEBON Q-RIP Belt, PediatricBraebon Medical CorporationBZQ2024-03-25
B1400573A0Q-RIP to Belt Controller Cable for AliceBraebon Medical CorporationBZQ2024-03-25
B1408592A0Q-RIP to Belt Controller Cable for AliceBraebon Medical CorporationBZQ2024-03-25
00851540007161ExSpiron Pediatric PadSetsSenzime AB (Publ.)BZQ2024-01-25
08809988780001Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)Xandar Kardian Korea Inc.BZQ2024-01-19
B1400585PESXA0BRAEBON Ultima Esophageal Pressure TransducerBraebon Medical CorporationBZQ2024-01-05
00195278699923PORTRAIT MMP01GE Healthcare Finland OyBZQ2023-10-26