FDA UDI
In Commercial Distribution
🇺🇸 United States
HOMEDICS
DI: 00031262099952
·
Model: PX-132CO
·
FKA DISTRIBUTING CO., LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- HOMEDICS
- Primary DI
- 00031262099952
- Version / Model
- PX-132CO
- Company Name
- FKA DISTRIBUTING CO., LLC
- Labeler DUNS
- 183280973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-03
- Public Version
- 4
- Public Version Date
- 2022-12-26
- Public Version Status
- Update
- Public Device Record Key
- 3770f6a1-5b1a-444b-8221-e08e4a75c5fd
Device Description
Pulse Oximeter
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00031262099952 | GS1 | ||||
| Package | 10031262099959 | GS1 | Master Case | 4 | In Commercial Distribution | |
| Package | 20031262099956 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 30031262099953 | GS1 | Master Case | 80 | In Commercial Distribution |