Identity
- Trade Name
- SURELOCK, CARDIOLINE, ORANGE, 10 PK FDA UDI
- Generic Name
- Electrocardiographic electrode, reusable FDA UDI
- Device Name
- SURELOCK, CARDIOLINE, ORANGE LEVER, 10 PACK FDA UDI
- Model / Reference
- 66020008 FDA UDI
- Description
- SURELOCK, CARDIOLINE, ORANGE LEVER, 10 PACK FDA UDI
Identifiers
- Catalog Number
- 28380 FDA UDI
- Primary DI / UDI-DI
- 00840828188944 FDA UDI
- 510(k) Number
- K080605 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Electrocardiographic electrode, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic electrode, reusable
Surelock, Cardioline, Orange, 10 Pk by Curbell Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080605 also covers:
- SURE LOCK, A34, 10 PK, BLUE LEVER, MIDMARK — CURBELL MEDICAL PRODUCTS, INC.
- SURE LOCK, A34, 10 PK, BLUE, PHILIPS/CURBELL — CURBELL MEDICAL PRODUCTS, INC.
- SURE LOCK, A34, 10 PK, GRN LEVER, CAREFUSION — CURBELL MEDICAL PRODUCTS, INC.
- SURE LOCK, A34, 14 PK, GRN LEVER, CAREFUSION — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, 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
- Curbell Medical Products, Inc.
Sources (1)
- FDA UDI 57740aef-7ae8-47d1-9720-6e524d53efe8 36 fields · synced May 30, 2026