FDA UDI
In Commercial Distribution
🇺🇸 United States
MTS
DI: 00869667000408
·
Model: OX-610A
·
MEDICAL TEST SUPPLY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MTS
- Primary DI
- 00869667000408
- Version / Model
- OX-610A
- Catalog Number
- OX610A
- Company Name
- MEDICAL TEST SUPPLY
- Labeler DUNS
- 064063916
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-13
- Public Version
- 4
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 0b0f5eed-eebd-40b8-8c71-bbc3c2c1220b
Device Description
The OX-610A Wrist Pulse Oximeter is fully automatic. It displays and records oxygen saturation (Spo2) and pulse rate (PR). It is motion tolerant and can be used during exercise and other daily activities.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| OCH | Oximeter, Infrared, Sporting, Aviation | Cardiovascular | 870.2700 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00869667000408 | GS1 |
Customer Contacts
- Phone
- 1-855-270-5357
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063641 | 000 |