FDA UDI
In Commercial Distribution
🇺🇸 United States
iCONNECT - AMPERE
DI: 04044508137048
·
Model: 82066
·
OSYPKA GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- iCONNECT - AMPERE
- Primary DI
- 04044508137048
- Version / Model
- 82066
- Catalog Number
- 001-009079-1
- Company Name
- OSYPKA GmbH
- Labeler DUNS
- 316276799
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-13
- Public Version
- 1
- Public Version Date
- 2026-03-23
- Public Version Status
- New
- Public Device Record Key
- c23d1f5a-8e7d-4cfc-8006-db39252b120f
Device Description
The system cables are used for the connection of different systems to the iCONNECT connection hub.
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPB | Cardiac Ablation Percutaneous Catheter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04044508137031 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 04044508137048 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240014 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 132 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius