FDA UDI
In Commercial Distribution
🇺🇸 United States
Unimed
DI: 06936735455270
·
Model: 94721UN
·
Unimed Medical Supplies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Unimed
- Primary DI
- 06936735455270
- Version / Model
- 94721UN
- Company Name
- Unimed Medical Supplies, Inc.
- Labeler DUNS
- 527971025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-13
- Public Version
- 2
- Public Version Date
- 2024-10-28
- Public Version Status
- Update
- Public Device Record Key
- cc985a64-a96a-449d-8284-abfc5a38f59b
Device Description
CAPTEUR SPO2 PATIENT UNIQUE NEONATAL -3KG +40KG COMPATIBLE NELLCOR OXIMAX L :0.9M DISPOSABLE SPO2 SENSOR NEONATAL -3KG +40KG NELLCOR OXIMAX COMPATIBLE L :0.9M
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 06936735455270 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142832 | 000 |