Identity
- Trade Name
- CPR Meter Patient Adhesive EUDAMEDHeartStart FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- Other Accessories EUDAMEDCPR meter adhesives, 10 pack FDA UDI
- Model / Reference
- 989803163291 EUDAMEDCPR Meter Patient Adhesive Pads FDA UDI
- Description
- CPR meter adhesives, 10 pack FDA UDI
Identifiers
- Catalog Number
- 989803163291 FDA UDI
- Primary DI / UDI-DI
- 00884838035256 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM484TE EUDAMED
- Unit of Use DI
- 00884838116689 EUDAMED
- FDA Product Code
- MKJ FDA UDIDRO FDA UDI
- EMDN Code
- Z12030585 DEFIBRILLATORS - CONSUMABLES EUDAMED
- GMDN Term
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Regulation Number
- 870.5310 FDA UDI870.5550 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CPR Meter Patient Adhesive by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM484TE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002128
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 4a78c7dc-3fec-489c-a251-89b95fb09611 61 fields · synced Jul 9, 2026
- FDA UDI fe479606-09ec-41b1-84c6-d7c878fb6410 37 fields · synced May 25, 2026