Identity
- Trade Name
- SCHILLER FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- The Maglife Serenity is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N20), partial pressure of inspired carbon dioxide, respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of oxygen (FiO2) and temperature tracking. FDA UDI
- Model / Reference
- MAGLIFE Serenity FDA UDI
- Description
- The Maglife Serenity is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N20), partial pressure of inspired carbon dioxide, respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of oxygen (FiO2) and temperature tracking. FDA UDI
Identifiers
- Catalog Number
- 1-094-9900 FDA UDI
- Primary DI / UDI-DI
- 07613365900002 FDA UDI
- 510(k) Number
- K023195 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor 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 Conditional FDA UDI
Category: General-purpose multi-parameter bedside monitor
Schiller by Schiller Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose multi-parameter bedside monitor.
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- Flying-V cuff LARGE — CNSystems Medizintechnik GmbH · Class II
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- IBP Adapter Cable — Orantech Inc. · Class I
- LiDCO — LIDCO LIMITED · Class II
- LiDCO — LIDCO LIMITED · Class II
Cleared under the same submission
K023195 also covers:
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
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
- Schiller Medical
Sources (1)
- FDA UDI c1f378f4-b975-4c27-aa81-6b392496def2 37 fields · synced May 30, 2026