Identity
- Trade Name
- ReviveR View Configuration FDA UDI
- Generic Name
- Non-rechargeable public semi-automated external defibrillator FDA UDI
- Model / Reference
- DDU-C2300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10815098020222 FDA UDI
- 510(k) Number
- K081259 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Non-rechargeable public semi-automated external defibrillator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ReviveR View Configuration by Defibtech, L.l.c. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K081259 also covers:
- DDU-1XXX/2XXX Adult Pads Adapter, Physio-Control Configuration — DEFIBTECH, L.L.C.
- DDU-1XXX/2XXX Adult Pads Adapter, Zoll Configuration — DEFIBTECH, L.L.C.
- DDU-1XXX/2XXX Series Adult Pads Adapter, Physio-Control — DEFIBTECH, L.L.C.
- DDU-1XXX/2XXX Series Adult Rescue Pads — DEFIBTECH, L.L.C.
- DDU-1XXX/2XXX Series Battery Pack — DEFIBTECH, L.L.C.
- DDU-1XXX/2XXX Series Battery Pack — DEFIBTECH, L.L.C.
- DDU-1XXX/2XXX Series Battery Pack Configuration — DEFIBTECH, L.L.C.
- DDU-1XXX/2XXX Series Pediatric Pads Configuration — DEFIBTECH, L.L.C.
- DDU-1XXX/2XXX Series Pediatric Rescue Pads — DEFIBTECH, L.L.C.
- DDU-2XXX Series Battery Pack Configuration — DEFIBTECH, L.L.C.
- Lifeline View — DEFIBTECH, L.L.C.
- Lifeline View — 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 87f0b3e4-f570-46cd-9e6a-b91e35df0a54 34 fields · synced Jun 1, 2026