FDA.reportPublic FDA data

Sibel Spacelabs Finger Patch Adhesive 3 day

Primary DI
00850064210231
Brand
Sibel Spacelabs Finger Patch Adhesive 3 day
Company
Sibel Health Inc.
Model
900-00042
Published
2025-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240305000ANNE LimbSibel Health, Inc.2024-05-28DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064210231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064210231008500642102318500642102310850064210231

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
093772547
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
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf Box900-000722025-12-17
00850064210286ANNE Link Mobile900-000692025-12-11
00850064210200Sibel Spacelabs Trek Chest Patch900-000392025-04-02
00850064210217Sibel Spacelabs Trek Finger Patch900-000412025-04-02
00850064210224Sibel Spacelabs Trek Charger900-000462025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch Adhesive900-000622025-04-02
00850064210255Sibel Spacelabs Trek Blood Pressure Cuff900-000452025-04-02
00850064210262Sibel Spacelabs Trek Tablet900-000432025-04-02
00860004541745ANNE Chest810-000122025-04-02
00860004541752ANNE Limb810-000132025-04-02
00850064210125ANNE Limb Adhesive Shelf Box900-000112025-03-27
00850064210163Central Hub CMS900-000132025-03-27
00850064210194Central Hub Speaker900-000042025-03-27
00850064210002ANNE Chest Sensor Kit900-000072025-03-26
008500642100197-Day ANNE Chest Adhesive Pouch900-000382025-03-26
008500642100261-Day ANNE Chest Adhesive Pouch900-000142025-03-26
00850064210057ANNE Bedside Wireless Charger900-000082025-03-26
00850064210088ANNE Limb Sensor Kit900-000032025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf Box900-000102025-03-26
00850064210132ANNE View Patient Monitor 900-000122025-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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