Identity
- Trade Name
- Fetal Monitor Remote Display FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Model / Reference
- 27 Wall Mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- B321600226000010 FDA UDI
- 510(k) Number
- K931133 FDA UDI
- FDA Product Code
- HGM FDA UDI
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 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
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 24 Pound FDA UDIHeight — 17 Inch FDA UDIWidth — 24 Inch FDA UDIDepth — 3.5 Inch FDA UDI
Category: Centralized patient monitor
Fetal Monitor Remote Display by Clinicomp International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K931133 also covers:
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.
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
- Clinicomp International, Inc.
Sources (1)
- FDA UDI 157bdbcf-c7cc-4b01-898c-fd73bf86c153 36 fields · synced May 30, 2026