Identity
- Trade Name
- 2-Slot AG/O2/BIS Module FDA UDI
- Generic Name
- Anaesthesia unit, mobile FDA UDI
- Model / Reference
- 115-056532-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936415919115 FDA UDI
- 510(k) Number
- K182075 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- GMDN Term
- Anaesthesia unit, mobile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5160 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: Anaesthesia unit, mobile
2-Slot AG/O2/BIS Module by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182075 also covers:
- 1-Slot CO2 Module — Shenzhen Mindray Bio-Medical Electronics Co.
- 1-Slot CO2 Module w/ kit (Neo) — Shenzhen Mindray Bio-Medical Electronics Co.
- 1-Slot CO2/O2 Module — Shenzhen Mindray Bio-Medical Electronics Co.
- 1-Slot CO2/O2 Module w/ kit (Neo) — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 12-Lead Host Cable — Shenzhen Mindray Bio-Medical Electronics Co.
- 19""display(adapter/5M) — Shenzhen Mindray Bio-Medical Electronics Co.
- 2-Slot AG/O2 Module — Shenzhen Mindray Bio-Medical Electronics Co.
- 2-Slot AG/O2/BIS w/ AG kit — Shenzhen Mindray Bio-Medical Electronics Co.
- 22""display(adapter/5M) — Shenzhen Mindray Bio-Medical Electronics Co.
- Bandage for NMT sensor — Shenzhen Mindray Bio-Medical Electronics Co.
- Bracket of SMR (Hook Bracket) — Shenzhen Mindray Bio-Medical Electronics Co.
- CCO/SvO2 Module w/ cable — 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 1d8456f8-8701-4d36-b325-b0c7f6311e97 34 fields · synced May 30, 2026