Identity
- Trade Name
- 1-Slot CO2/O2 Module w/ kit (Adult/Ped) FDA UDI
- Generic Name
- Carbon dioxide sensor/cable FDA UDI
- Model / Reference
- 115-049136-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936415902636 FDA UDI
- 510(k) Number
- K170876 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Carbon dioxide sensor/cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Carbon dioxide sensor/cable
1-Slot CO2/O2 Module w/ kit (Adult/Ped) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Carbon dioxide sensor/cable.
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- AirLife™ — Airlife, Inc. · Class II
- 1-Slot CO2/O2 Module — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- 1-Slot CO2 Module w/ kit (Neo) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- 1-Slot CO2/O2 Module w/ kit (Neo) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- 1-Slot CO2 Module w/ kit (Adult/Ped) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- RM Module(package/no accessory) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K170876 also covers:
- 1-Slot CO2 Module w/ kit (Adult/Ped) — Shenzhen Mindray Bio-Medical Electronics Co.
- 115-046935-00 — Shenzhen Mindray Bio-Medical Electronics Co.
- 1ed Hook Material Package(international) — Shenzhen Mindray Bio-Medical Electronics Co.
- 8pin masimo Cable — Shenzhen Mindray Bio-Medical Electronics Co.
- BIS module kit(Package/no accessory) — Shenzhen Mindray Bio-Medical Electronics Co.
- Bedrail hook TDS handle — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO_AG Module(with 02)(FDA)II — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO_AG Module(with 02)(FDA/FJ)II — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO_SidestreamCO2 module(FDA)II — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO_SidestreamCO2 module(FDA/FJ)II — Shenzhen Mindray Bio-Medical Electronics Co.
- NMT Module (Package/no accessory) — Shenzhen Mindray Bio-Medical Electronics Co.
- NMT Module w/ kit — Shenzhen Mindray Bio-Medical Electronics Co.
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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI adade4cd-1dec-45cc-b1dd-5897866d75fa 34 fields · synced May 30, 2026