FDA UDI
In Commercial Distribution
🇺🇸 United States
BRAUN
DI: 06921745201191
·
Model: BPX801US
·
Xuzhou Yongkang Electronic Science Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BRAUN
- Primary DI
- 06921745201191
- Version / Model
- BPX801US
- Company Name
- Xuzhou Yongkang Electronic Science Technology Co., Ltd
- Labeler DUNS
- 542753796
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-17
- Public Version
- 1
- Public Version Date
- 2025-06-25
- Public Version Status
- New
- Public Device Record Key
- ec3afc26-c248-4509-8277-eae801b71d0e
Device Description
The Braun Pulse oximeter (BPX801) is a non-sterile, reusable device intended for spot checking or intermittent determination of oxygen saturation in arterial blood, as well as the associated pulse rate by using the tip of the finger as the measurement site. The device is intended for adults 21 year of age or older, in a home-use environment (such as a home setting or places of business).
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
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 |
|---|---|---|---|---|---|---|
| Package | 16921745201198 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 06921745201191 | GS1 | ||||
| Package | 26921745201195 | GS1 | 6 | In Commercial Distribution |