Identity
- Trade Name
- Trident 3-Lead Cable FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Trident™ 40 3-Electrode Cable FDA UDI
- Model / Reference
- H3R-0017 FDA UDI
- Description
- Trident™ 40 3-Electrode Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331013887 FDA UDI
- 510(k) Number
- K102507 FDA UDI
- FDA Product Code
- DSI FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic ambulatory recorder
Trident 3-Lead Cable by Tz Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102507 also covers:
- 3 LEAD HOLTER CABLE — Tz Medical, Inc.
- 3 Lead MCT Monitor GMed Variant — Tz Medical, Inc.
- 3 Lead MCT Monitor Zoll Variant — Tz Medical, Inc.
- 3-Lead LTE MCT Monitor GMED — Tz Medical, Inc.
- 3-Lead LTE MCT Monitor ZOLL — Tz Medical, Inc.
- 4 Lead Holter Cable — Tz Medical, Inc.
- Gang Charger for 9 Holter Devices — Tz Medical, Inc.
- H3R CLARUS POWER SUPPLY — Tz Medical, Inc.
- H3R Cable 3 lead — Tz Medical, Inc.
- H3R Cable 4 Electrode — Tz Medical, Inc.
- H3R Holster — Tz Medical, Inc.
- H3R USB Cable — Tz Medical, Inc.
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
- Tz Medical, Inc.
Sources (1)
- FDA UDI bec3fa2f-6866-44a7-9bcc-ce428ee17a58 34 fields · synced Jun 8, 2026