Identity
- Trade Name
- Vivo 45 LS FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Power Cord US FDA UDI
- Model / Reference
- 003522 FDA UDI
- Description
- Power Cord US FDA UDI
Identifiers
- Catalog Number
- 003522 FDA UDI
- Primary DI / UDI-DI
- 07321820035229 FDA UDI
- 510(k) Number
- K193586 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrical-only medical device connection cable, reusable
Vivo 45 LS by Breas Medical AB — 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
K193586 also covers:
- Vivo 45 LS — BREAS MEDICAL, INC.
- Vivo 45 LS — BREAS MEDICAL, INC.
- Vivo 45 LS — BREAS MEDICAL, INC.
- Vivo 45 LS — BREAS MEDICAL, INC.
- Vivo 45 LS, Vivo 65 — BREAS MEDICAL, INC.
- Vivo 45 LS, Vivo 65 — BREAS MEDICAL, INC.
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — Breas Medical AB
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Breas Medical AB
Sources (2)
- FDA UDI 3f9577bb-b4e4-4c9d-bf88-d24ed2370ef0 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026