Identity
- Trade Name
- DLW,4 LEAD,PINCH,CARESCAPE,40",AHA FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Model / Reference
- DLW-04BG-40AS-0000 FDA UDI
Identifiers
- Catalog Number
- 29118 FDA UDI
- Primary DI / UDI-DI
- 00840828193214 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Electrocardiographic electrode, single-use 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic electrode, single-use
Dlw, 4 Lead, Pinch, Carescape, 40", Aha 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
K081762 also covers:
- 3-LD DIN ECG CABLE, A — CURBELL MEDICAL PRODUCTS, INC.
- 3-LD ECG CABLE, MOLDED, SNAP, A — CURBELL MEDICAL PRODUCTS, INC.
- 3-LD ECG CABLE, MOLDED, SNAP, A — CURBELL MEDICAL PRODUCTS, INC.
- 3-LD ECG CABLE, MOLDED, SNAP, A, RISISTO — CURBELL MEDICAL PRODUCTS, INC.
- 3-LD TWIN ECG CABLE, ACUSON SEQUOIA /90 — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD DIN ECG CABLE, A — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD ECG CABLE DATEX TO GE LEADS — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD ECG CABLE, MOLDED, SNAP, A — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD TWIN ECG CABLE, A — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD TWIN ECG CABLE, A — CURBELL MEDICAL PRODUCTS, INC.
- CBL 024, PLP, MLD, 3LEAD, SNAP, 10FT, AHA — CURBELL MEDICAL PRODUCTS, INC.
- CBL 024, PLP, TWINPIN, 5LEAD, YOKE10FT, AHA — 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 7060b06b-a738-4b3b-b10e-abfa5ababff5 35 fields · synced May 30, 2026