FDA.reportPublic FDA data

ANNE Limb Sensor Kit

Primary DI
00850064210088
Brand
ANNE Limb Sensor Kit
Company
Sibel Health Inc.
Model
900-00003
Device description
ANNE Limb is a pulse oximeter intended for continuous monitoring of SpO2, pulse rate, and skin temperature.
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064210088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064210088008500642100888500642100880850064210088

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093772547
Device count
1
Lot or batch
true
Serial number
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
00850064210231Sibel Spacelabs Finger Patch Adhesive 3 day900-000422025-04-02
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
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
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09