Identity
- Trade Name
- AG Module(O2/package/accessory) FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Model / Reference
- 115-044874-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904096636 FDA UDI
- 510(k) Number
- K190011 FDA UDI
- FDA Product Code
- CBR FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1700 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: General-purpose multi-parameter bedside monitor
AG Module (O2 +2 more) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS
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Cleared under the same submission
K190011 also covers:
- 19"display(adapter/10M/VP1) — Shenzhen Mindray Bio-Medical Electronics Co.
- 19"display(adapter/2.3M — Shenzhen Mindray Bio-Medical Electronics Co.
- 22"display(adapter/2.3M — Shenzhen Mindray Bio-Medical Electronics Co.
- BIS module (w accessory kit) — Shenzhen Mindray Bio-Medical Electronics Co.
- CCO/Sco2 interface module kit(FRU) — Shenzhen Mindray Bio-Medical Electronics Co.
- CCO/Sco2 interface module(FRU) — Shenzhen Mindray Bio-Medical Electronics Co.
- CCO/SvO2 update kit(international) — Shenzhen Mindray Bio-Medical Electronics Co.
- ICG module (w accessory kit) — Shenzhen Mindray Bio-Medical Electronics Co.
- SCVO2 Module(Package/no accessory) — Shenzhen Mindray Bio-Medical Electronics Co.
- SMR integrated mount accessory Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- ScvO2 Module — Shenzhen Mindray Bio-Medical Electronics Co.
- ScvO2 function upgrade 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 2ed6713b-cc25-4f6a-8a7c-54b72771bf53 34 fields · synced May 31, 2026