FDA UDI
In Commercial Distribution
🇺🇸 United States
Replacement Finger Probes
DI: 05060488570360
·
Model: 20260
·
PROACTIVE MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Replacement Finger Probes
- Primary DI
- 05060488570360
- Version / Model
- 20260
- Catalog Number
- 20260
- Company Name
- PROACTIVE MEDICAL PRODUCTS, LLC
- Labeler DUNS
- 078582655
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 3
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 416d6b7e-555a-4c2b-a792-2e7ab1544a8d
Device Description
MASIMO 8 PIN REPLACEMENT FINGER PROBE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37808 | Pulse oximeter probe, reusable | A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060488570360 | GS1 |
Customer Contacts
- Phone
- +1 855 237 7622
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 1 | Inch | |
| Length | 1 | Inch | |
| Width | 2 | Inch |