Identity
- Trade Name
- EMMA™ Kit FDA UDI
- Generic Name
- Patient monitoring system module, carbon dioxide FDA UDI
- Device Name
- EMMA™ Kit FDA UDI
- Model / Reference
- 3678 FDA UDI
- Description
- EMMA™ Kit FDA UDI
Identifiers
- Catalog Number
- 3678 FDA UDI
- Primary DI / UDI-DI
- 07350046131040 FDA UDI
- GMDN Term
- Patient monitoring system module, carbon dioxide FDA UDI
Classification
- 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
Yes
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
No
FDA UDI
Category: Patient monitoring system module, carbon dioxide
EMMA™ Kit by Masimo Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, carbon dioxide.
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- etCO2 PodKit w/Clamp + Sensor — Draeger Medical Systems, Inc. · Class II
- ORIDION CO2 mod upgrd kit, intl — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Spacelabs — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- etCO2 PodKit w/Holder+Sensor — Draeger Medical Systems, Inc. · Class II
- IBP_CO_MicrostreamCO2 module(FDA/FJ/PK.) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- single CO2 Module (Package/no accessory) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA UDI 83b78e44-4400-479a-b936-9d808a64527e 34 fields · synced Jun 8, 2026