Infinity Trident NMT SmartPod
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Infinity Trident NMT SmartPod EUDAMEDFDA UDI
- Generic Name
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
- Model / Reference
- 7876910 EUDAMEDFDA UDI007139 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098007139 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049098007139 EUDAMED
- 510(k) Number
- K042003 FDA UDI
- FDA Product Code
- KOI FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2775 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Block-monitoring peripheral nerve electrical stimulation system
Infinity Trident NMT SmartPod by Draeger Medical Systems, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (2)
- FDA UDI 3ecfa1eb-87ad-4e3d-b525-51b09fe5ace1 34 fields · synced Jul 23, 2026
- EUDAMED 5a64e88f-3568-4d9c-adc4-b44664785fcb 61 fields · synced Jul 23, 2026