Identity
- Trade Name
- Life Sensing Instruments, Inc. FDA UDI
- Generic Name
- Multiple-patient intensive/general healthcare physiologic monitoring system FDA UDI
- Device Name
- Transmitter which is part of a multi-patient physiologic monitoring system FDA UDI
- Model / Reference
- TM8D Transmitter FDA UDI
- Description
- Transmitter which is part of a multi-patient physiologic monitoring system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864037000309 FDA UDI
- 510(k) Number
- K896967 FDA UDI
- FDA Product Code
- DSI FDA UDI
- GMDN Term
- Multiple-patient intensive/general healthcare physiologic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
No
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: Multiple-patient intensive/general healthcare physiologic monitoring system
Life Sensing Instruments, Inc. by Life Sensing Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-patient intensive/general healthcare physiologic monitoring system.
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- 5-Lead, New Telemetry, Disp, AHA, Snap, 24″ — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
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- 3-Lead, New Telemetry, IEC, Pinch, 24″ — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K896967 also covers:
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.
- Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, 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 |
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Manufacturer
- Manufacturer
- Life Sensing Instruments, Inc.
Sources (1)
- FDA UDI d6b82fd3-df3f-446a-9009-74ee17e40425 35 fields · synced May 30, 2026