FDA UDI
In Commercial Distribution
🇺🇸 United States
ANNE Limb
DI: 00860004541752
·
Model: 810-00013
·
Sibel Health Inc.
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ANNE Limb
- Primary DI
- 00860004541752
- Version / Model
- 810-00013
- Company Name
- Sibel Health Inc.
- Labeler DUNS
- 093772547
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-02
- Public Version
- 1
- Public Version Date
- 2025-04-10
- Public Version Status
- New
- Public Device Record Key
- 33de8e38-0060-45c7-a2cc-98207d3f1aed
Device Description
ANNE Limb is a pulse oximeter intended for continuous monitoring of SpO2, pulse rate, and skin temperature.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860004541752 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240305 | 000 |