Identity
- Trade Name
- Spo2 Probe (Lumenair™ and Model TS4) FDA UDI
- Generic Name
- Pulse oximeter, line-powered FDA UDI
- Device Name
- Spo2 Probe (Lumenair™ and Model TS4) FDA UDI
- Model / Reference
- Model Lumenair FDA UDI
- Description
- Spo2 Probe (Lumenair™ and Model TS4) FDA UDI
Identifiers
- Catalog Number
- V83-0253 FDA UDI
- Primary DI / UDI-DI
- 00817980021327 FDA UDI
- 510(k) Number
- K033617 FDA UDI
- FDA Product Code
- DRN FDA UDI
- GMDN Term
- Pulse oximeter, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5225 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter, line-powered
Spo2 Probe (Lumenair™ and Model TS4) by Vasomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter, line-powered.
- BCI — ICU MEDICAL, INC. · Class II
- Reusable Sensor - Y — MEDIAID INC · Class II
- Reusable Sensor - Ear — MEDIAID INC · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- BCI — ICU MEDICAL, INC. · Class II
- BCI — ICU MEDICAL, INC. · Class II
- Caring Mill — Caring Mill · Class II
- Reusable Sensor - Compushield (SCS) — MEDIAID INC · Class II
Cleared under the same submission
K033617 also covers:
- 3 Lead Integrated ECG Cable (AngioNew® V & VI) — VASOMEDICAL, INC.
- 3 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™) — VASOMEDICAL, INC.
- AnKle Strap — VASOMEDICAL, INC.
- Bladder Set, Large — VASOMEDICAL, INC.
- Bladder Set, Medium — VASOMEDICAL, INC.
- Bladder Set, Small — VASOMEDICAL, INC.
- Bladder Set, X-Large (should be used with XL and XXL cuffs) — VASOMEDICAL, INC.
- Bladder Set, X-Small — VASOMEDICAL, INC.
- Calf Cuff, Small, Medium & Large — VASOMEDICAL, INC.
- Calf Cuff, X-Large — VASOMEDICAL, INC.
- Calf Cuff, X-Small — VASOMEDICAL, INC.
- Calf Cuff, XX-Large — VASOMEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vasomedical, Inc.
Sources (1)
- FDA UDI f3c672cf-2493-4d2e-87ef-e4008cbaa699 36 fields · synced Jun 8, 2026