Identity
- Trade Name
- Bio Protech FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- PT2334 Resting Tabs- 23x34mm Resting ECG Tabs (5,000 pcs in Master Case/ 25,000 pcs in a Full Master Carton). FDA UDI
- Model / Reference
- PT2334 Resting Tabs FDA UDI
- Description
- PT2334 Resting Tabs- 23x34mm Resting ECG Tabs (5,000 pcs in Master Case/ 25,000 pcs in a Full Master Carton). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817120020555 FDA UDI
- 510(k) Number
- K040784 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic electrode, single-use
Bio Protech by Bio Protech Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K040784 also covers:
- Vyaire — Airlife, Inc.
- Vyaire — Airlife, Inc.
- Vyaire — Airlife, Inc.
- Vyaire — Airlife, Inc.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Baxter — BIOPROTECH INC.
- CareFusion — BIOPROTECH INC.
- CareFusion — BIOPROTECH INC.
- CareFusion — BIOPROTECH INC.
- CareFusion — BIOPROTECH INC.
- Henry Schein — HENRY SCHEIN, 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
- Bio Protech Usa, Inc.
Sources (1)
- FDA UDI 214aeb20-6946-42bf-bf6d-7dd2fddea803 35 fields · synced May 30, 2026