AccessGUDID - DEVICE: ANNE Limb (00860004541752)

GUDID

Device Identifier (DI) Information

Brand Name: ANNE Limb
Version or Model: 810-00013
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sibel Health Inc.

Primary DI Number: 00860004541752
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093772547 *Terms of Use

Device Description: ANNE Limb is a pulse oximeter intended for continuous monitoring of SpO2, pulse rate, and skin temperature.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45607	Pulse oximeter	An 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.	Active	false
65831	Wearable multiple vital physiological parameter monitor	A portable assembly of electrically-powered devices intended to be worn by an ambulatory patient in a healthcare setting for intermittent assessment or continuous monitoring of several vital physiologic parameters [e.g., electrocardiogram (ECG), respiration rate, haemoglobin oxygen saturation (SpO2)] while allowing freedom of movement (e.g., in step-down care areas). It includes processing hardware to be used with dedicated software (that may be pre-installed); the sensors, probes, and/or electrodes are not included. It typically incorporates a monitoring screen and may allow communication with a stationary device (e.g., off-the shelf computer).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240305	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33de8e38-0060-45c7-a2cc-98207d3f1aed
Public Version Date: April 10, 2025
Public Version Number: 1
DI Record Publish Date: April 02, 2025