Identity
- Trade Name
- DM4 FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates. FDA UDI
- Model / Reference
- 91331-MF FDA UDI
- Description
- The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates. FDA UDI
Identifiers
- Catalog Number
- 91331-MF FDA UDI
- Primary DI / UDI-DI
- 00851920007354 FDA UDI
- 510(k) Number
- K150620 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Multiple vital physiological parameter monitoring system, clinical
Dm4 by Zoe Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150620 also covers:
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
- 740 SELECT — ZOE MEDICAL INCORPORATED
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
- Zoe Medical Incorporated
Sources (1)
- FDA UDI d8aa6190-a46f-47e9-98d8-abe6ea5dbfb2 37 fields · synced Jun 8, 2026