FDA UDI
In Commercial Distribution
🇺🇸 United States
MOBI
DI: 00891040702999
·
Model: 70299
·
MOBI TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MOBI
- Primary DI
- 00891040702999
- Version / Model
- 70299
- Company Name
- MOBI TECHNOLOGIES, INC.
- Labeler DUNS
- 137468570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-11
- Public Version
- 1
- Public Version Date
- 2021-02-19
- Public Version Status
- New
- Public Device Record Key
- 95a5f9e5-c2b3-4b3e-8e95-0b1615e431b4
- Distribution End Date
- 2025-12-31
Device Description
MOBI’s Fingertip Pulse Oximeter offers a noninvasive method for monitoring oxygen salutation. Though its reading of peripheral oxygen saturation (SPO2). It is portable, lightweight and multi-functional that can perform the measurement within 10 seconds.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17148 | Pulse oximeter, line-powered | A mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10891040702996 | GS1 | Cardboard | 6 | In Commercial Distribution | 2025-12-31 |
| Primary | 00891040702999 | GS1 | ||||
| Package | 20891040702993 | GS1 | Cardboard | 4 | In Commercial Distribution | 2025-12-31 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173123 | 000 |