Identity
- Trade Name
- Bio Protech FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- T815-5: TElectrode, Cloth, 55 mm Round, Stress & Holter, 5/pouch; 20pouch/Box; 1000pcs/master case FDA UDI
- Model / Reference
- T815-5 FDA UDI
- Description
- T815-5: TElectrode, Cloth, 55 mm Round, Stress & Holter, 5/pouch; 20pouch/Box; 1000pcs/master case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817120020166 FDA UDI
- 510(k) Number
- K020003 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
K020003 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.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- CareFusion — BIOPROTECH 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 7c15720a-8f3f-4ff6-9cb2-61b393560cbd 35 fields · synced Jun 8, 2026