IBP Y-cable 16P TO 10 Pin
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- IBP Y-KABLE 16-AUF 10-POLIG EUDAMEDIBP Y-cable 16P TO 10 Pin FDA UDI
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Model / Reference
- 5731281 EUDAMEDFDA UDI1070276K19Z270 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098008273 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867521070276K19Z270UK EUDAMED
- 510(k) Number
- K070566 FDA UDI
- FDA Product Code
- DSA FDA UDIMHX FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Portable/mobile rechargeable battery pack FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI870.1025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Portable/mobile rechargeable battery pack
IBP Y-cable 16P TO 10 Pin by Draeger Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Portable/mobile rechargeable battery pack.
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Cleared under the same submission
K070566 also covers:
- CARDIAC OUTPUT KIT BAXTER — Draeger Medical Systems, Inc.
- Delta Monitor — Draeger Medical Systems, Inc.
- DeltaXL Monitor — Draeger Medical Systems, Inc.
- ECG 3 lead, Euro, Telemetry — Draeger Medical Systems, Inc.
- ECG 3-LEAD DUAL-PIN AHA/US, 1M — Draeger Medical Systems, Inc.
- ECG 5 lead Euro Telemetry — Draeger Medical Systems, Inc.
- ECG 5-LEAD SINGLE-PIN AHA, 1M — Draeger Medical Systems, Inc.
- ECG 5-LEAD TRUST AHU/US, TELEM — Draeger Medical Systems, Inc.
- ECG 6-LEAD SINGLE-PIN AHA, 1M — Draeger Medical Systems, Inc.
- ECG 6-LEAD TRUST AHA/US, TELEM — Draeger Medical Systems, Inc.
- ECG 6-Lead, Dual-P Euro 1M — Draeger Medical Systems, Inc.
- ECG CBL 4-LD SINGLE-PIN EUR 1M — Draeger Medical Systems, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (2)
- FDA UDI 0ef0c33b-9519-46a8-8613-b2929e3d79cc 34 fields · synced Jul 26, 2026
- EUDAMED 811a396a-b5e8-419e-aea6-e1a6676be034 61 fields · synced Jul 26, 2026