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Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- USE: Application for ECG monitoring or diagnosis with the connected equipment as medical sensors. INSTRUCTIONS: 1. Patient's skin should be clean and dry and free of excessive hair. 2. Remove electrode from backing material. 3. Press electrode to skin around the outer edge. Continue to move pressure toward the center for best adhesive. 4. Attach lead wire to the electrode, START ECG PROCEDURE. CAUTIONS: 1. Only for hospital or physician. 2. Keep any unused electrode in the original recloseable pouch. 3. Electrode use not recommended for more than 72 hours. FDA UDI
- Model / Reference
- 7102 FDA UDI
- Description
- USE: Application for ECG monitoring or diagnosis with the connected equipment as medical sensors. INSTRUCTIONS: 1. Patient's skin should be clean and dry and free of excessive hair. 2. Remove electrode from backing material. 3. Press electrode to skin around the outer edge. Continue to move pressure toward the center for best adhesive. 4. Attach lead wire to the electrode, START ECG PROCEDURE. CAUTIONS: 1. Only for hospital or physician. 2. Keep any unused electrode in the original recloseable pouch. 3. Electrode use not recommended for more than 72 hours. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784710228 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic electrode, single-use
Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Dynarex Corp.
Sources (1)
- FDA UDI 8a1717ab-49f1-4d9a-9280-47ddb2b09306 33 fields · synced May 30, 2026