Identity
- Trade Name
- IBP_CO_MicrostreamCO2 module(FDA/FJ/PK.) FDA UDI
- Generic Name
- Patient monitoring system module, carbon dioxide FDA UDI
- Model / Reference
- 115-030783-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904086118 FDA UDI
- 510(k) Number
- K153448 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Patient monitoring system module, carbon dioxide 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
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: Patient monitoring system module, carbon dioxide
IBP_CO_MicrostreamCO2 module - FJ by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — 3 models
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Also classified as Patient monitoring system module, carbon dioxide.
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- etCO2 PodKit w/Clamp + Sensor — Draeger Medical Systems, Inc. · Class II
- Spacelabs — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- etCO2 PodKit w/Holder+Sensor — Draeger Medical Systems, Inc. · Class II
- EMMA™ — MASIMO CORPORATION · Class II
Cleared under the same submission
K153448 also covers:
- BP_CO_AG Module(with 02)(FDA/FJ/PK.) — Shenzhen Mindray Bio-Medical Electronics Co.
- Cardiac Output Cable (12Pin) — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP module(FDA/FJ/PK..) — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO module(FDA/FJ/PK.) — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO_AG Module(with 02)(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO_MicrostreamCO2module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO_SidestreamCO2 module(FDA/FJ/PK.) — Shenzhen Mindray Bio-Medical Electronics Co.
- IBP_CO_SidestreamCO2 module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co.
- KIT, MICROSTREAM, T5/T8, DPM6/7 — Shenzhen Mindray Bio-Medical Electronics Co.
- Patient Monitor Passport 12 — 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 27238f40-d497-458b-aa78-db6cac1bb39d 34 fields · synced May 30, 2026