Identity
- Trade Name
- Wall Mounting Bracket Packgae FDA UDI
- Generic Name
- Patient monitoring system module rack FDA UDI
- Model / Reference
- 115-030109-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904086408 FDA UDI
- 510(k) Number
- K150632 FDA UDI
- FDA Product Code
- MSX FDA UDI
- GMDN Term
- Patient monitoring system module rack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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 rack
Wall Mounting Bracket Packgae 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
K150632 also covers:
- 0155 Signal Converter Package — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, AHA, Pinch, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, AHA, Pinch, 36″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, AHA, Snap, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, AHA, Snap, 36″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, Disp, AHA, Snap, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, Disp, IEC, Snap, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, IEC, Pinch, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, IEC, Pinch, 36″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, IEC, Snap, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, IEC, Snap, 36″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 4-channel Receiving Cabinet Package — 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 3f2d361f-d9bc-4d9b-bf30-9a6c355a99e9 34 fields · synced Jun 6, 2026