PK-175/2, 3m
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- PK-175 EUDAMEDPK-175/2,3m FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- 333959 EUDAMEDFDA UDITemp. pacing cable EUDAMED
Identifiers
- Catalog Number
- 333959 FDA UDI
- Primary DI / UDI-DI
- 04035479049300 EUDAMEDFDA UDI
- Basic UDI-DI
- 4035479BUDI00091QF EUDAMED
- Direct Marketing DI
- 04035479049300 EUDAMED
- PMA Number
- P950037 FDA UDI
- FDA Product Code
- DTE FDA UDI
- EMDN Code
- Z12050680 NON-IMPLANTABLE CARDIAC STIMULATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.3600 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
Manufacturing Date
No
Category: Electrical-only medical device connection cable, reusable
PK-175/2, 3m by BIOTRONIK SE & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- MICTEC CONNECTION CABLE — SONTEC INSTRUMENTS, INC. · Class II
- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
P950037 also covers:
- Amvia Sky HF-T QP — BIOTRONIK SE & Co. KG
- DH — BIOTRONIK SE & Co. KG
- EFH-6F-W — BIOTRONIK SE & Co. KG
- Evity 6 DR-T — BIOTRONIK SE & Co. KG
- Home Monitoring Service Center — BIOTRONIK SE & Co. KG
- Home Monitoring Service Center — BIOTRONIK SE & Co. KG
- M-50 — BIOTRONIK SE & Co. KG
- NEO 2401.U/1 — BIOTRONIK SE & Co. KG
- PK Electrode Clip — BIOTRONIK SE & Co. KG
- PK-222 US/2, 8m — BIOTRONIK SE & Co. KG
- PK-83-B/2, 5m — BIOTRONIK SE & Co. KG
- Renamic — BIOTRONIK SE & Co. KG
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
- BIOTRONIK SE & Co. KG
Sources (2)
- FDA UDI ded523ef-38bb-4c1b-9e64-4e2685ba733a 36 fields · synced Oct 6, 2026
- EUDAMED ee4e5f57-8391-45d7-99ea-91ad7c040a63 61 fields · synced Aug 1, 2026