Identity
- Trade Name
- DDU-1XX Series Adult Rescue Pads FDA UDI
- Generic Name
- External defibrillation electrode, adult, single-use FDA UDI
- Model / Reference
- DDP-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815098020423 FDA UDI
- 510(k) Number
- K013896 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- External defibrillation electrode, adult, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External defibrillation electrode, adult, single-use
DDU-1XX Series Adult Rescue Pads by Defibtech, L.l.c. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External defibrillation electrode, adult, single-use.
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Cleared under the same submission
K013896 also covers:
- DDU-1XX Series Battery Pack — DEFIBTECH, L.L.C.
- DDU-1XX Series Battery Pack — DEFIBTECH, L.L.C.
- DDU-1XX Series Battery Pack Configuration — DEFIBTECH, L.L.C.
- DDU-1XX series Battery Pack Configuration — DEFIBTECH, L.L.C.
- Lifeforce — DEFIBTECH, L.L.C.
- Lifeline — DEFIBTECH, L.L.C.
- Lifeline — DEFIBTECH, L.L.C.
- Lifeline Configuration — DEFIBTECH, L.L.C.
- Lifeline Configuration — DEFIBTECH, L.L.C.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Defibtech, L.l.c.
Sources (1)
- FDA UDI 439139c0-127b-4c20-ad28-b8eaab5e4cd1 33 fields · synced May 30, 2026