Identity
- Trade Name
- SJM™ FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reprocessed FDA UDI
- Device Name
- Electrophysiology Cable FDA UDI
- Model / Reference
- IBI-85641 FDA UDI
- Description
- Electrophysiology Cable FDA UDI
Identifiers
- Catalog Number
- IBI-85641 FDA UDI
- Primary DI / UDI-DI
- 05414734308755 FDA UDI
- PMA Number
- P040014 FDA UDI
- FDA Product Code
- LPB FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reprocessed FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Feet FDA UDI
Category: Electrical-only medical device connection cable, reprocessed
Sjm™ by Irvine Biomedical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrical-only medical device connection cable, reprocessed.
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Cleared under the same submission
P040014 also covers:
- SJM™ — IRVINE BIOMEDICAL, INC.
- SJM™ — IRVINE BIOMEDICAL, INC.
- SJM™ — IRVINE BIOMEDICAL, INC.
- SJM™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
- Therapy™ — IRVINE BIOMEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Irvine Biomedical, Inc.
Sources (1)
- FDA UDI acec8660-bedc-492a-a803-14a90e14ee86 38 fields · synced May 30, 2026