Identity
- Trade Name
- Night Shift EUDAMEDFDA UDI
- Generic Name
- Behavioural therapy electrical stimulation system FDA UDI
- Device Name
- Night Shift EUDAMEDNight Shift Chest Belt Kit Standard (45") FDA UDI
- Model / Reference
- NS27-4102 EUDAMEDFDA UDI
- Description
- Night Shift Chest Belt Kit Standard (45") FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015266492 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851113007NS27ACCRM EUDAMED
- 510(k) Number
- K140190 FDA UDI
- FDA Product Code
- MNR FDA UDIMYB FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Behavioural therapy electrical stimulation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI872.5570 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary function analysis system, adult
Night Shift by Advanced Brain Monitoring, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0851113007NS27ACCRM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Advanced Brain Monitoring, Inc.
- EUDAMED SRN
- US-MF-000011252
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 75702067-7ca7-4f6e-80c7-7aec6146b6b6 61 fields · synced Jun 8, 2026
- FDA UDI 0ac487f7-c4bd-40e2-8fd9-662c1ef40cde 34 fields · synced May 30, 2026