FDA UDI
In Commercial Distribution
🇺🇸 United States
SJM™
DI: 05414734308755
·
Model: IBI-85641
·
IRVINE BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SJM™
- Primary DI
- 05414734308755
- Version / Model
- IBI-85641
- Catalog Number
- IBI-85641
- Company Name
- IRVINE BIOMEDICAL, INC.
- Labeler DUNS
- 926346966
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-10-31
- Public Version
- 4
- Public Version Date
- 2023-02-21
- Public Version Status
- Update
- Public Device Record Key
- acec8660-bedc-492a-a803-14a90e14ee86
Device Description
Electrophysiology Cable
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPB | Cardiac ablation percutaneous catheter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46429 | Electrical-only medical device connection cable, reprocessed | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a single-use device previously used that has been reprocessed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414734308755 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040014 | 000 |
| P040014 | 046 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Feet |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep in a cool, dry place