FDA UDI
In Commercial Distribution
🇺🇸 United States
Sapphire Connect Power Supply
DI: 17290109154494
·
Model: 15072-121-1055
·
EITAN MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Sapphire Connect Power Supply
- Primary DI
- 17290109154494
- Version / Model
- 15072-121-1055
- Company Name
- EITAN MEDICAL LTD
- Labeler DUNS
- 533108028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-26
- Public Version
- 1
- Public Version Date
- 2023-04-03
- Public Version Status
- New
- Public Device Record Key
- 5167c8ab-4e7c-4f43-84a3-e87beddef392
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 Safe
- 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 |
|---|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36545 | Basic power supply, reusable | A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290109154491 | GS1 | cardboard box | 10 | In Commercial Distribution | |
| Primary | 17290109154494 | GS1 | ||||
| Direct Marking | 07290109154497 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192860 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity