FDA UDI
In Commercial Distribution
🇺🇸 United States
BluPRO®
DI: 10841983102711
·
Model: TL-271T3
·
NIHON KOHDEN AMERICA, INC.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- BluPRO®
- Primary DI
- 10841983102711
- Version / Model
- TL-271T3
- Catalog Number
- TL-271T3
- Company Name
- NIHON KOHDEN AMERICA, INC.
- Labeler DUNS
- 021063219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 5f477f42-3b8a-4635-ac98-74642ddf6720
Device Description
SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 160cm cable
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GWQ | Full-montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Cardiovascular | 870.2300 | 2 |
| DRG | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY | Cardiovascular | 870.2910 | 2 |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31658 | Pulse oximeter probe, single-use | 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. The is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841983102711 | GS1 | ||||
| Unit of Use | 00841983102714 | GS1 |
Customer Contacts
- Phone
- +1(800)325-0283
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Adult |