FDA UDI
In Commercial Distribution
🇺🇸 United States
Splitter- US
DI: 17290109150274
·
Model: 15043-000-0005
·
EITAN MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Splitter- US
- Primary DI
- 17290109150274
- Version / Model
- 15043-000-0005
- Catalog Number
- 15043-000-0005
- Company Name
- EITAN MEDICAL LTD
- Labeler DUNS
- 533108028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-24
- Public Version
- 4
- Public Version Date
- 2022-11-23
- Public Version Status
- Update
- Public Device Record Key
- 120a97ff-6a06-408f-a0ba-fa6c6c5d5f70
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 42498 | Intravenous pole multi-outlet holder | A mains electricity (AC-powered) device used with an intravenous (IV) pole (usually of the floor-standing type) and designed to provide multiple electrical outlet sockets so that an electrical source is made available when two or more infusion pumps are mounted into the retaining slots provided. This device will fit onto a standard IV pole and is intended to accept the mounting of a number of infusion pumps, keeping them safely fastened to the pole in an organized manner. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07290109150277 | GS1 | ||||
| Package | 27290109150271 | GS1 | cardboard box | 60 | In Commercial Distribution | |
| Primary | 17290109150274 | GS1 | ||||
| Package | 27290109150585 | GS1 | cardboard box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-241-4002
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123049 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius