Identity
- Trade Name
- Unetixs Vascular FDA UDI
- Generic Name
- Limb plethysmograph FDA UDI
- Device Name
- The MultiLab Series 2 LHS is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular system. FDA UDI
- Model / Reference
- Multilab Series 2 LHS FDA UDI
- Description
- The MultiLab Series 2 LHS is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular system. FDA UDI
Identifiers
- Catalog Number
- 11949-0000-01 FDA UDI
- Primary DI / UDI-DI
- B4371194904 FDA UDI
- 510(k) Number
- K904392 FDA UDI
- FDA Product Code
- JAF FDA UDI
- GMDN Term
- Limb plethysmograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1540 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Limb plethysmograph
Unetixs Vascular by Unetixs Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K904392 also covers:
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 |
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Manufacturer
- Manufacturer
- Unetixs Vascular, Inc.
Sources (1)
- FDA UDI 16669290-21fc-4998-a822-b6f0624ac416 35 fields · synced Jun 8, 2026